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Taking people in United StatesPhase 2

Tests blinatumomab with or without nivolumab in relapsed B-cell acute lymphoblastic leukemia

Tests nivolumab added to blinatumomab in people with returned B-cell acute lymphoblastic leukemia.

Key facts

Who runs it
National Cancer Institute (NCI)
Where
Akron, Albany, Albuquerque, Allentown, Anaheim, Anchorage, Ann Arbor, Arroyo Grande, Asheville, Atlanta, Aurora, Austin, Baltimore, Bangor, Battle Creek, Bellevue, Bellflower, Bethesda, Birmingham, Boise, Boston, Bridgeport, Brooklyn, Burlington, Carson City, Chapel Hill, Charleston, Charlotte, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Corpus Christi, Dallas, Danville, Dayton, Dearborn, Denver, Des Moines, Detroit, Downey, Duarte, Durham, East Lansing, El Paso, Falls Church, Fargo, Fontana, Fort Myers, Fort Worth, Gainesville, Grand Rapids, Green Bay, Greenville, Hackensack, Hartford, Henderson, Hershey, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Kalamazoo, Kansas City, Kingman, Knoxville, Las Vegas, Lebanon, Lexington, Little Rock, Loma Linda, Long Beach, Los Angeles, Louisville, Lubbock, Madera, Madison, Martinsburg, Maywood, Mesa, Milwaukee, Mineola, Minneapolis, Mobile, Morgantown, Morristown, Muskegon, Nashville, New Brunswick, New Hyde Park, New Orleans, New York, Newark, Niles, Norfolk, Norton Shores, Oakland, Oklahoma City, Omaha, Orange, Orlando, Pahrump, Palo Alto, Parkersburg, Paterson, Pensacola, Peoria, Philadelphia, Phoenix, Pittsburgh, Portland, Providence, Reed City, Reno, Renton, Richmond, Rochester, Royal Oak, Sacramento, Saint Joseph, Salt Lake City, San Antonio, San Diego, San Francisco, Savannah, Scarborough, Seattle, Sioux Falls, Spokane, St Louis, St. Petersburg, Stony Brook, Sylvania, Syracuse, Tacoma, Tampa, The Bronx, Toledo, Torrance, Traverse City, Troy, Tucson, Tulsa, Washington D.C., West Palm Beach, Wilmington, Winston-Salem, Wyoming, and Yakima, United StatesSee the 213 sitesAlso in 3 other countries, 16 sites
Trial code
Registry title
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Status
Recruiting
Phase
Phase 2
People taking part
461 people, planned
Started
17 Dec 2020
Expected to end
30 Jun 2028
Type of study
Interventional, 9 groups
Treatments tested
  • 3-Dimensional Conformal Radiation Therapy
  • Asparaginase Erwinia chrysanthemi
  • Biospecimen Collection
  • Blinatumomab
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Calaspargase Pegol
  • Cytarabine
  • Dexamethasone
  • Hydrocortisone Sodium Succinate
  • Lumbar Puncture
  • Mercaptopurine
  • Methotrexate
  • Nivolumab
  • Pegaspargase
  • Vincristine Sulfate
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people aged 1 to 30 whose B-cell acute lymphoblastic leukemia (B-ALL) has come back for the first time. People with Down syndrome can join too.

Age
1 year to 30 years
Sex
All sexes
Disease stage
First relapse of CD19+ B-ALL. Relapse blasts must express CD19. Relapse may be in the bone marrow, the central nervous system or the testes.
Earlier treatment
Must have recovered from the side effects of earlier chemotherapy, immunotherapy or radiotherapy. Must not have had a stem cell transplant before. Earlier blinatumomab or CD19 CAR therapy is allowed if the relapsed cells still have CD19.
Biomarker or test result
Leukemia cells must have CD19 on them.

Main reasons for not taking part

  • B-lymphoblastic lymphoma, Burkitt leukemia/lymphoma or mixed phenotype acute leukemia
  • Philadelphia chromosome positive B-ALL or ABL class Ph-like B-ALL
  • Active uncontrolled infection, or uncontrolled HIV, hepatitis B or hepatitis C
  • Active or suspected autoimmune disease (some mild forms are allowed), or serious nervous system disease that rules out blinatumomab
  • A bone marrow failure syndrome such as Fanconi anemia

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Patients must be >= 1 and < 31 years at time of enrollment
  • Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:; Isolated bone marrow relapse; Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse; Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
  • Patients with Down syndrome (DS) are eligible in the following categories:; Isolated bone marrow relapse; Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study; Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression; Patients must not have had a prior hematopoietic stem cell transplant; A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted; In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible; Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) >= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required; Patients with Down syndrome who received pre-enrollment therapy and have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy; Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment):; Age: Maximum serum creatinine (mg/dL); 1 to < 2 years: 0.6 (male), 0.6 (female); 2 to < 6 years: 0.8 (male), 0.8 (female); 6 to < 10 years: 1 (male), 1 (female); 10 to < 13 years: 1.2 (male), 1.2 (female); 13 to < 16 years: 1.5 (male), 1.4 (female); >= 16 years: 1.7 (male), 1.4 (female); The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)
  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram
  • No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Who cannot take part

  • Patients with active, uncontrolled infection defined as:; Positive bacterial blood culture within 48 hours of study enrollment; Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline; Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for > 48 hours; A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection; Active viral or protozoal infection requiring IV treatment
  • Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible
  • Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible
  • Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement; Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab
  • Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose
  • Patients with known Charcot-Marie-Tooth disease
  • Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible; Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease
  • Patients with B-lymphoblastic lymphoma (B-LLy)
  • Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
  • Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)
  • Patients with mixed phenotype acute leukemia (MPAL)
  • Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 30 years old?

Where in United States

Also in 3 other countries, 16 sites

  • Children's Hospital Medical Center of AkronAkron, United StatesContact: Lauren R. Draper (principal investigator)Taking people
  • Albany Medical CenterAlbany, United StatesContact: Lauren R. Weintraub (principal investigator)Taking people
  • Presbyterian HospitalAlbuquerque, United StatesContact: Beeling Armijo (principal investigator)Taking people
  • Lehigh Valley Hospital-Cedar CrestAllentown, United StatesContact: Jacob A. Troutman (principal investigator)Taking people
  • Kaiser Permanente-AnaheimAnaheim, United StatesNo longer taking part
  • Providence Alaska Medical CenterAnchorage, United StatesContact: Brenda J. Wittman (principal investigator)Taking people
  • C S Mott Children's HospitalAnn Arbor, United StatesContact: Joshua W. Goldman (principal investigator)Taking people
  • PCR OncologyArroyo Grande, United StatesNo longer taking part
  • Mission HospitalAsheville, United StatesContact: Douglas J. Scothorn (principal investigator)Taking people
  • Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesContact: Waitman K. Aumann (principal investigator)Taking people
  • Children's Hospital ColoradoAurora, United StatesContact: Kelly E. Faulk (principal investigator)Taking people
  • Dell Children's Medical Center of Central TexasAustin, United StatesContact: Shannon M. Cohn (principal investigator)Taking people
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesContact: Stacy L. Cooper (principal investigator)Taking people
  • Sinai Hospital of BaltimoreBaltimore, United StatesContact: Jason M. Fixler (principal investigator)Taking people
  • Eastern Maine Medical CenterBangor, United StatesTaking people
  • Bronson Battle CreekBattle Creek, United StatesNo longer taking part
  • Overlake Medical CenterBellevue, United StatesNo longer taking part
  • Kaiser Permanente-BellflowerBellflower, United StatesNo longer taking part
  • Walter Reed National Military Medical CenterBethesda, United StatesNo longer taking part
  • Children's Hospital of AlabamaBirmingham, United StatesContact: Matthew A. Kutny (principal investigator)Taking people
  • Saint Luke's Cancer Institute - BoiseBoise, United StatesContact: Martha M. Pacheco (principal investigator)Taking people
  • Tufts Children's HospitalBoston, United StatesNo longer taking part
  • United Hospital CenterBridgeport, United StatesNo longer taking part
  • Maimonides Medical CenterBrooklyn, United StatesContact: Mahmut Y. Celiker (principal investigator)Taking people
  • University of Vermont and State Agricultural CollegeBurlington, United StatesContact: Jessica L. Heath (principal investigator)Taking people
  • Carson Tahoe Regional Medical CenterCarson City, United StatesNo longer taking part
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesContact: Thomas B. Alexander (principal investigator)Taking people
  • Vandalia Health/CAMC Institute for Academic MedicineCharleston, United StatesContact: Mohamad H. Badawi (principal investigator)Taking people
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesContact: Joel A. Kaplan (principal investigator)Taking people
  • Lurie Children's Hospital-ChicagoChicago, United StatesContact: Jenna Rossoff (principal investigator)Taking people
  • University of Chicago Comprehensive Cancer CenterChicago, United StatesContact: Gabrielle Lapping-Carr (principal investigator)Taking people
  • University of IllinoisChicago, United StatesContact: Dipti S. Dighe (principal investigator)Taking people
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Erin H. Breese (principal investigator)Taking people
  • Rainbow Babies and Childrens HospitalCleveland, United StatesContact: Duncan S. Stearns (principal investigator)Taking people
  • Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
  • Prisma Health Richland HospitalColumbia, United StatesContact: Stuart L. Cramer (principal investigator)Taking people
  • Nationwide Children's HospitalColumbus, United StatesContact: Mark A. Ranalli (principal investigator)Taking people
  • Driscoll Children's HospitalCorpus Christi, United StatesContact: Nkechi I. Mba (principal investigator)Taking people
  • Medical City Dallas HospitalDallas, United StatesContact: Maurizio L. Ghisoli (principal investigator)Taking people
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesContact: Tamra L. Slone (principal investigator)Taking people
  • Geisinger Medical CenterDanville, United StatesContact: Jagadeesh Ramdas (principal investigator)Taking people
  • Dayton Children's HospitalDayton, United StatesContact: Jordan M. Wright (principal investigator)Taking people
  • Corewell Health Dearborn HospitalDearborn, United StatesNo longer taking part
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenver, United StatesContact: Florence Choo (principal investigator)Taking people
  • Blank Children's HospitalDes Moines, United StatesContact: Samantha L. Mallory (principal investigator)Taking people
  • Children's Hospital of MichiganDetroit, United StatesNo longer taking part
  • Kaiser Permanente Downey Medical CenterDowney, United StatesContact: Robert M. Cooper (principal investigator)Taking people
  • City of Hope Comprehensive Cancer CenterDuarte, United StatesNo longer taking part
  • Duke University Medical CenterDurham, United StatesContact: Jessica M. Sun (principal investigator)Taking people
  • Michigan State UniversityEast Lansing, United StatesNo longer taking part
  • El Paso Children's HospitalEl Paso, United StatesContact: Benjamin Carcamo (principal investigator)Taking people
  • Inova Fairfax HospitalFalls Church, United StatesContact: Robin Y. Dulman (principal investigator)Taking people
  • Sanford Broadway Medical CenterFargo, United StatesContact: Samuel J. Milanovich (principal investigator)Taking people
  • Kaiser Permanente-FontanaFontana, United StatesContact: Robert M. Cooper (principal investigator)Taking people
  • Golisano Children's Hospital of Southwest FloridaFort Myers, United StatesContact: Emad K. Salman (principal investigator)Taking people
  • Cook Children's Medical CenterFort Worth, United StatesContact: Kenneth M. Heym (principal investigator)Taking people
  • UF Health Cancer Institute - GainesvilleGainesville, United StatesContact: Brian Stover (principal investigator)Taking people
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesNo longer taking part
  • Trinity Health Grand Rapids HospitalGrand Rapids, United StatesNo longer taking part
  • Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesContact: Catherine A. Long (principal investigator)Taking people
  • BI-LO Charities Children's Cancer CenterGreenville, United StatesContact: Aniket Saha (principal investigator)Taking people
  • East Carolina UniversityGreenville, United StatesContact: Andrea R. Whitfield (principal investigator)Taking people
  • Prisma Health Cancer Institute - EastsideGreenville, United StatesContact: Aniket Saha (principal investigator)Taking people
  • Hackensack University Medical CenterHackensack, United StatesContact: Jing Chen (principal investigator)Taking people
  • Connecticut Children's Medical CenterHartford, United StatesContact: Michael S. Isakoff (principal investigator)Taking people
  • Comprehensive Cancer Centers of Nevada - HendersonHenderson, United StatesNo longer taking part
  • Comprehensive Cancer Centers of Nevada-Horizon RidgeHenderson, United StatesNo longer taking part
  • Comprehensive Cancer Centers of Nevada-Southeast HendersonHenderson, United StatesNo longer taking part
  • Las Vegas Cancer Center-HendersonHenderson, United StatesNo longer taking part
  • Penn State Children's HospitalHershey, United StatesContact: Lisa M. McGregor (principal investigator)Taking people
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesContact: Iftikhar Hanif (principal investigator)Taking people
  • Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesContact: Wade T. Kyono (principal investigator)Taking people
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesContact: Anil George (principal investigator)Taking people
  • UT MD Anderson Cancer CenterHouston, United StatesContact: Najat C. Daw (principal investigator)Taking people
  • Ascension Saint Vincent Indianapolis HospitalIndianapolis, United StatesContact: Bassem I. Razzouk (principal investigator)Taking people
  • Riley Hospital for ChildrenIndianapolis, United StatesContact: Sandeep Batra (principal investigator)Taking people
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesContact: Andrew P. Groves (principal investigator)Taking people
  • University of Mississippi Medical CenterJackson, United StatesContact: Amanda Strobel (principal investigator)Taking people
  • Nemours Children's Clinic-JacksonvilleJacksonville, United StatesContact: Emi H. Caywood (principal investigator)Taking people
  • Bronson Methodist HospitalKalamazoo, United StatesContact: Kathleen Y. Butler (principal investigator)Taking people
  • Beacon KalamazooKalamazoo, United StatesNo longer taking part
  • West Michigan Cancer CenterKalamazoo, United StatesNo longer taking part
  • Children's Mercy Hospitals and ClinicsKansas City, United StatesContact: Keith J. August (principal investigator)Taking people
  • Kingman Regional Medical CenterKingman, United StatesNo longer taking part
  • East Tennessee Childrens HospitalKnoxville, United StatesContact: Susan E. Spiller (principal investigator)Taking people
  • Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesContact: Joseph L. Lasky (principal investigator)Taking people
  • Summerlin Hospital Medical CenterLas Vegas, United StatesContact: Joseph L. Lasky (principal investigator)Taking people
  • Ann M Wierman MD LTDLas Vegas, United StatesNo longer taking part
  • Comprehensive Cancer Centers of NevadaLas Vegas, United StatesNo longer taking part
  • Comprehensive Cancer Centers of Nevada - Central ValleyLas Vegas, United StatesNo longer taking part
  • Comprehensive Cancer Centers of Nevada - NorthwestLas Vegas, United StatesNo longer taking part
  • Comprehensive Cancer Centers of Nevada - Town CenterLas Vegas, United StatesNo longer taking part
  • Comprehensive Cancer Centers of Nevada-SummerlinLas Vegas, United StatesNo longer taking part
  • Hope Cancer Care of NevadaLas Vegas, United StatesNo longer taking part
  • Las Vegas Cancer Center-Medical CenterLas Vegas, United StatesNo longer taking part
  • OptumCare Cancer Care at CharlestonLas Vegas, United StatesNo longer taking part
  • OptumCare Cancer Care at Fort ApacheLas Vegas, United StatesNo longer taking part
  • OptumCare Cancer Care at MountainViewLas Vegas, United StatesNo longer taking part
  • Sunrise Hospital and Medical CenterLas Vegas, United StatesNo longer taking part
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesContact: Angela Ricci (principal investigator)Taking people
  • University of Kentucky/Markey Cancer CenterLexington, United StatesContact: James T. Badgett (principal investigator)Taking people
  • Arkansas Children's HospitalLittle Rock, United StatesContact: Michael W. Bishop (principal investigator)Taking people
  • Loma Linda University Medical CenterLoma Linda, United StatesContact: Albert Kheradpour (principal investigator)Taking people
  • Miller Children's and Women's Hospital Long BeachLong Beach, United StatesContact: Jacqueline N. Casillas (principal investigator)Taking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Nicole M. Baca (principal investigator)Taking people
  • Children's Hospital Los AngelesLos Angeles, United StatesContact: Jamie L. Stokke (principal investigator)Taking people
  • Mattel Children's Hospital UCLALos Angeles, United StatesContact: Satiro N. De Oliveira (principal investigator)Taking people
  • Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesNo longer taking part
  • Norton Children's HospitalLouisville, United StatesContact: Michael J. Ferguson (principal investigator)Taking people
  • Covenant Children's HospitalLubbock, United StatesContact: Kishor M. Bhende (principal investigator)Taking people
  • UMC Cancer Center / UMC Health SystemLubbock, United StatesContact: Erin K. Barr (principal investigator)Taking people
  • Valley Children's HospitalMadera, United StatesContact: Ruetima Titapiwatanakun (principal investigator)Taking people
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesContact: Cathy A. Lee-Miller (principal investigator)Taking people
  • WVUH-Berkely Medical CenterMartinsburg, United StatesNo longer taking part
  • Loyola University Medical CenterMaywood, United StatesContact: Eugene Suh (principal investigator)Taking people
  • Banner Children's at DesertMesa, United StatesContact: Joseph C. Torkildson (principal investigator)Taking people
  • Children's Hospital of WisconsinMilwaukee, United StatesContact: Michael J. Burke (principal investigator)Taking people
  • NYU Langone Hospital - Long IslandMineola, United StatesContact: Chana L. Glasser (principal investigator)Taking people
  • Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, United StatesContact: Michael K. Richards (principal investigator)Taking people
  • University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesContact: Peter M. Gordon (principal investigator)Taking people
  • USA Health Strada Patient Care CenterMobile, United StatesContact: Hamayun Imran (principal investigator)Taking people
  • West Virginia University HealthcareMorgantown, United StatesContact: Ashley E. Meyer (principal investigator)Taking people
  • Morristown Medical CenterMorristown, United StatesContact: Kathryn L. Laurie (principal investigator)Taking people
  • Trinity Health Muskegon HospitalMuskegon, United StatesNo longer taking part
  • The Children's Hospital at TriStar CentennialNashville, United StatesContact: Clinton M. Carroll (principal investigator)Taking people
  • Vanderbilt University/Ingram Cancer CenterNashville, United StatesContact: Brianna N. Smith (principal investigator)Taking people
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesContact: Richard A. Drachtman (principal investigator)Taking people
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, United StatesContact: Richard A. Drachtman (principal investigator)Taking people
  • Saint Peter's University HospitalNew Brunswick, United StatesContact: Nibal A. Zaghloul (principal investigator)Taking people
  • The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, United StatesContact: Julie I. Krystal (principal investigator)Taking people
  • Children's Hospital New OrleansNew Orleans, United StatesContact: Maria C. Velez-Yanguas (principal investigator)Taking people
  • Ochsner Medical Center JeffersonNew Orleans, United StatesNo longer taking part
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesContact: Elizabeth A. Raetz (principal investigator)Taking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Kavitha Ramaswamy (principal investigator)Taking people
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesContact: Nobuko Hijiya (principal investigator)Taking people
  • NYP/Weill Cornell Medical CenterNew York, United StatesContact: Jaclyn Rosenzweig (principal investigator)Taking people
  • Newark Beth Israel Medical CenterNewark, United StatesContact: Teena Bhatla (principal investigator)Taking people
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesNo longer taking part
  • Children's Hospital of The King's DaughtersNorfolk, United StatesContact: Melissa S. Mark (principal investigator)Taking people
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United StatesNo longer taking part
  • Kaiser Permanente-OaklandOakland, United StatesContact: Aarati V. Rao (principal investigator)Taking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: Rene Y. McNall-Knapp (principal investigator)Taking people
  • Children's Hospital and Medical Center of OmahaOmaha, United StatesContact: Jill C. Beck (principal investigator)Taking people
  • University of Nebraska Medical CenterOmaha, United StatesContact: Jill C. Beck (principal investigator)Taking people
  • Children's Hospital of Orange CountyOrange, United StatesContact: Elyssa M. Rubin (principal investigator)Taking people
  • AdventHealth OrlandoOrlando, United StatesContact: Fouad M. Hajjar (principal investigator)Taking people
  • Arnold Palmer Hospital for ChildrenOrlando, United StatesContact: Jaime M. Libes-Bander (principal investigator)Taking people
  • Nemours Children's HospitalOrlando, United StatesContact: Emi H. Caywood (principal investigator)Taking people
  • Hope Cancer Care of Nevada-PahrumpPahrump, United StatesNo longer taking part
  • Lucile Packard Children's Hospital Stanford UniversityPalo Alto, United StatesContact: Jay Michael S. Balagtas (principal investigator)Taking people
  • Camden Clark Medical CenterParkersburg, United StatesNo longer taking part
  • Saint Joseph's Regional Medical CenterPaterson, United StatesContact: Alissa Kahn (principal investigator)Taking people
  • Nemours Children's Clinic - PensacolaPensacola, United StatesContact: Jeffrey H. Schwartz (principal investigator)Taking people
  • Sacred Heart HospitalPensacola, United StatesNo longer taking part
  • OSF Children's Hospital of IllinoisPeoria, United StatesContact: Prerna Kumar (principal investigator)Taking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Shannon L. Maude (principal investigator)Taking people
  • Saint Christopher's Hospital for ChildrenPhiladelphia, United StatesContact: Gregory E. Halligan (principal investigator)Taking people
  • Phoenix Childrens HospitalPhoenix, United StatesContact: Dana B. Salzberg (principal investigator)Taking people
  • Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesContact: Jenny Ruiz (principal investigator)Taking people
  • Legacy Emanuel Children's HospitalPortland, United StatesContact: Jason M. Glover (principal investigator)Taking people
  • Oregon Health and Science UniversityPortland, United StatesContact: Bill H. Chang (principal investigator)Taking people
  • Rhode Island HospitalProvidence, United StatesContact: Bradley DeNardo (principal investigator)Taking people
  • Corewell Health Reed City HospitalReed City, United StatesNo longer taking part
  • Renown Regional Medical CenterReno, United StatesContact: Seema L. Rao (principal investigator)Taking people
  • Cancer Care Specialists RenoReno, United StatesNo longer taking part
  • Saint Mary's Regional Medical CenterReno, United StatesNo longer taking part
  • Valley Medical CenterRenton, United StatesNo longer taking part
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesContact: Jordyn R. Griffin (principal investigator)Taking people
  • University of RochesterRochester, United StatesNo longer taking part
  • Corewell Health Children'sRoyal Oak, United StatesContact: Marie V. Nelson (principal investigator)Taking people
  • Corewell Health William Beaumont University HospitalRoyal Oak, United StatesNo longer taking part
  • Sutter Medical Center SacramentoSacramento, United StatesContact: Sandra Baril (principal investigator)Taking people
  • University of California Davis Comprehensive Cancer CenterSacramento, United StatesContact: Marcio H. Malogolowkin (principal investigator)Taking people
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesNo longer taking part
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesNo longer taking part
  • Primary Children's HospitalSalt Lake City, United StatesContact: Luke D. Maese (principal investigator)Taking people
  • Children's Hospital of San AntonioSan Antonio, United StatesContact: Julie Voeller (principal investigator)Taking people
  • Methodist Children's Hospital of South TexasSan Antonio, United StatesContact: Jose M. Esquilin (principal investigator)Taking people
  • University of Texas Health Science Center at San AntonioSan Antonio, United StatesContact: Anne-Marie R. Langevin (principal investigator)Taking people
  • Kaiser Permanente-San Diego ZionSan Diego, United StatesContact: Robert M. Cooper (principal investigator)Taking people
  • Rady Children's Hospital - San DiegoSan Diego, United StatesContact: William D. Roberts (principal investigator)Taking people
  • UCSF Medical Center-Mission BaySan Francisco, United StatesContact: Karen R. Rabin (principal investigator)Taking people
  • Memorial Health University Medical CenterSavannah, United StatesContact: James N. Yarnall (principal investigator)Taking people
  • Maine Children's Cancer ProgramScarborough, United StatesContact: Eric C. Larsen (principal investigator)Taking people
  • Seattle Children's HospitalSeattle, United StatesContact: Sarah E. Leary (principal investigator)Taking people
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesContact: Jordan Fritch-Hanson (principal investigator)Taking people
  • Providence Sacred Heart Medical Center and Children's HospitalSpokane, United StatesContact: Judy L. Felgenhauer (principal investigator)Taking people
  • Cardinal Glennon Children's Medical CenterSt Louis, United StatesContact: William S. Ferguson (principal investigator)Taking people
  • Mercy Hospital Saint LouisSt Louis, United StatesContact: Robin D. Hanson (principal investigator)Taking people
  • Washington University School of MedicineSt Louis, United StatesContact: Kristin Zorn (principal investigator)Taking people
  • Johns Hopkins All Children's HospitalSt. Petersburg, United StatesContact: Jennifer L. Mayer (principal investigator)Taking people
  • Stony Brook University Medical CenterStony Brook, United StatesContact: Laura E. Hogan (principal investigator)Taking people
  • ProMedica Flower HospitalSylvania, United StatesNo longer taking part
  • State University of New York Upstate Medical UniversitySyracuse, United StatesContact: Melanie A. Comito (principal investigator)Taking people
  • Madigan Army Medical CenterTacoma, United StatesContact: Melissa A. Forouhar (principal investigator)Taking people
  • Mary Bridge Children's Hospital and Health CenterTacoma, United StatesContact: Robert G. Irwin (principal investigator)Taking people
  • Saint Joseph's Hospital/Children's Hospital-TampaTampa, United StatesContact: Don E. Eslin (principal investigator)Taking people
  • Tampa General HospitalTampa, United StatesContact: Andrew J. Galligan (principal investigator)Taking people
  • Montefiore Medical Center - Moses CampusThe Bronx, United StatesContact: Alice Lee (principal investigator)Taking people
  • ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, United StatesContact: Jamie L. Dargart (principal investigator)Taking people
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesNo longer taking part
  • Munson Medical CenterTraverse City, United StatesNo longer taking part
  • Corewell Health Beaumont Troy HospitalTroy, United StatesNo longer taking part
  • Banner University Medical Center - TucsonTucson, United StatesContact: Monica M. Davini (principal investigator)Taking people
  • Saint Francis Children's HospitalTulsa, United StatesContact: Jill A. Salo (principal investigator)Taking people
  • Children's National Medical CenterWashington D.C., United StatesContact: Jeffrey S. Dome (principal investigator)Taking people
  • MedStar Georgetown University HospitalWashington D.C., United StatesContact: Caileigh Pudela (principal investigator)Taking people
  • Saint Mary's Medical CenterWest Palm Beach, United StatesContact: Matthew D. Ramirez (principal investigator)Taking people
  • Alfred I duPont Hospital for ChildrenWilmington, United StatesContact: Emi H. Caywood (principal investigator)Taking people
  • Wake Forest University Health SciencesWinston-Salem, United StatesContact: Sarah Supples (principal investigator)Taking people
  • University of Michigan Health - WestWyoming, United StatesNo longer taking part
  • North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, United StatesNo longer taking part

About the trial

What the trial wants to find out

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

The 9 groups in the trial

  • Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patientsTreatment being tested

    Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11 of cycle 1 and day 3 of cycle 2, and MTX IT (for patients with CNS1/2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \< 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with MRD \<0.01% at the end of Cycle 1 may stop study treatment at the discretion of the treating physician. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, Methotrexate, and Nivolumab

  • Group 1, Arm A (dexamethasone, blinatumomab, MTX)Treatment being tested

    ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1, 15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given \< 7 days prior to the start of this cycle), and MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9/19/2024)

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, and Methotrexate

  • Group 1, Arm B (dexamethasone, blinatumomab, MTX)Treatment being tested

    Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9/19/2024)

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, Methotrexate, and Nivolumab

  • Group 2, Arm C (dexamethasone, blinatumomab, MTX)Treatment being tested

    Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1 and 2, and methotrexate IT on days 1 and 15 of cycles 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal therapy is given \< 7 days prior to the start of this cycle). Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9/19/2024)

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Dexamethasone, Lumbar Puncture, and Methotrexate

  • Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX)Treatment being tested

    Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9/19/2024)

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Dexamethasone, Lumbar Puncture, Methotrexate, and Nivolumab

  • Group 3, Arm E (dexamethasone, blinatumomab, MTX)Treatment being tested

    See Outline section

    Treatment: 3-Dimensional Conformal Radiation Therapy, Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Calaspargase Pegol, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, Mercaptopurine, Methotrexate, Pegaspargase, and Vincristine Sulfate

  • Group 3, Arm F (dexamethasone, blinatumomab, nivolumab)Treatment being tested

    See Outline section

    Treatment: 3-Dimensional Conformal Radiation Therapy, Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Calaspargase Pegol, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, Mercaptopurine, Methotrexate, Nivolumab, Pegaspargase, and Vincristine Sulfate

  • Group 4 Arm I (Dexamethasone, blinatumomab, nivolumab)Treatment being tested

    Patients receive dexamethasone PO or IV on day 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV, over 30 minutes on day 11 of cycle 1 and day 3 of cycle 2 and MTX IT on days 1 of cycle 1 only and days 15 and 36 ( for patients with CNS1/2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \< 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Calaspargase Pegol, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, Methotrexate, and Nivolumab

  • Group 4, Arm H (dexamethasone blinatumomab)Treatment being tested

    Patients receive dexamethasone PO or IV on day 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28 and MTX IT on days 1 of cycle 1 only and days 15 and 36 ( for patients with CNS1/2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \< 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.

    Treatment: Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Dexamethasone, Hydrocortisone Sodium Succinate, Lumbar Puncture, and Methotrexate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged &gt;/= 1 to &lt; 31 Years Old With First Relapse
Plain-language title
Tests blinatumomab with or without nivolumab in relapsed B-cell acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04546399, who can take part
Publications
Record updated
12 November 2026