NCT02981628Active, not recruitingPhase 2
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 29 Nov 2016
- Start date
- 19 Jun 2017
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Children's Oncology Group
- NCT number
- NCT02981628
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 19 Jun 2017 to the primary completion date, 31 Dec 2026
- 157 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with any prior history of SOS irrespective of severity
- Patients who have been previously treated with inotuzumab ozogamicin
- Patients who have previously received HSCT (Cohort 2 only)
- Patients who are currently receiving another investigational drug
- Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)
- Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications
- Patients who are currently receiving or plan to receive corticosteroids except as described below
- Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications
- Patients who have an active uncontrolled infection defined as:
- Positive bacterial blood culture within 48 hours of study enrollment;
- Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability
- A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
- Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as 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
- 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, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome
- There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment
- Female 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 their study participation and for 8 months after the last dose of inotuzumab ozogamicin
- Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin
- Lactating females are not eligible unless they agree not to breastfeed their infants
Other illness
- Patients with Down syndrome (Cohort 2 only)
- History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study
- Note: Patients with history of allergy to pegaspargase/calaspargase pegol are eligible for enrollment on Cohort 2 if Erwinia formulation of asparaginase can be obtained
- Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient
Other
- Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse
- Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement
Who the study is looking for
- Patients must be \>= 1 year and \< 22 years of age at the time of enrollment
- Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with \>= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
- NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study
- Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing \>= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method
- Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin \[PE\] is strongly recommended)
- In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
- Patients with one of the following:
- Second or greater relapse;
- Primary refractory disease with at least 2 prior induction attempts;
- First relapse refractory to at least one prior re-induction attempt
- Any relapse after HSCT (Cohort 1 ONLY)
- Patients with Down syndrome are eligible ONLY for Cohort 1 with:
- Any of above disease status, OR
- First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy
- Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =\< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. Apply to Cohort 2:
- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
- A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate).
- A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment
- \>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, \>= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy.
- Note: Cytoreduction with hydroxyurea must be discontinued \>= 24 hours prior to the start of protocol therapy.
- Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): \>= 7 days after the last dose of agent. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment.
- Anti-cancer agents that are antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria.
- Corticosteroids: If used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction.
- Radiotherapy: \>= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); \>= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if \>= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; \>= 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
- Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.
- Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion
- 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; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- 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:
- 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to \< 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- \>= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
- Direct bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
- Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L
Age in the registry: 1 year to 21 years · Sex: All · Does not accept healthy volunteers
Sites (157)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HIMA San Pablo Oncologic Hospital Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Lehigh Valley Hospital-Cedar Crest Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Tufts Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Maimonides Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| T C Thompson Children's Hospital Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Lurie Children's Hospital-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| University of Missouri Children's Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Medical City Dallas Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Blank Children's Hospital Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Kaiser Permanente Downey Medical Center Coordinator of this site? Confirm its status | Downey | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Michigan State University Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
| El Paso Children's Hospital Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| UF Health Cancer Institute - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Penn State Children's Hospital Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Ascension Saint Vincent Indianapolis Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Children's Mercy Hospitals and Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Sunrise Hospital and Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| UMC Cancer Center / UMC Health System Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Covenant Children's Hospital Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Saint Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Banner Children's at Desert Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| West Virginia University Healthcare Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| The Children's Hospital at TriStar Centennial Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Saint Peter's University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| The Steven and Alexandra Cohen Children's Medical Center of New York Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Children's Hospital New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of The King's Daughters Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Children's Hospital and Medical Center of Omaha Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Lucile Packard Children's Hospital Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Saint Joseph's Regional Medical Center Coordinator of this site? Confirm its status | Paterson | United States | Unknown status |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| OSF Children's Hospital of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Saint Christopher's Hospital for Children Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Legacy Emanuel Children's Hospital Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Corewell Health Children's Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Sutter Medical Center Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Primary Children's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Children's Hospital of South Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Children's Hospital of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Maine Children's Cancer Program Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Cardinal Glennon Children's Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Banner University Medical Center - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Saint Mary's Medical Center Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| UMass Memorial Medical Center - University Campus Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.