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NCT04315324Active, not recruitingPhase 1/2

Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)

A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

This phase I/II trial studies the safety, side effects and best dose of OBI-3424 and how well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
67 (estimated)
First submitted
18 Mar 2020
Start date
8 Feb 2021
Primary completion date
28 Oct 2025
Lead sponsor
SWOG Cancer Research Network
NCT number
NCT04315324

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 67
  • From 8 Feb 2021 to the primary completion date, 28 Oct 2025
  • 163 sites in 1 country
  • 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.

Who the study is looking for

  • Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Patients with relapsed/refractory T-cell lymphoblastic lymphoma are eligible if lymphoblasts are \>= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry
  • Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have \>= 5% lymphoblasts in the peripheral blood or bone marrow within 14 days prior to registration. Patients with only extramedullary disease are not eligible
  • Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients \< 18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles (example: induction and consolidation)
    • A standard chemotherapy induction regimen is defined as any program of treatment that includes:
    • Vincristine and corticosteroids plus at least one more chemotherapy agent
    • Cytarabine and anthracycline, or
    • High dose cytarabine (defined as at least 1 gr/m\^2 per individual dose unless adjustments were required for renal/liver function)
  • Patients must have no evidence of central nervous system disease within 28 days prior to registration based on cerebrospinal fluid (CSF) studies. Patients with clinical signs or symptoms consistent with central nervous system (CNS) involvement must have a lumbar puncture which is negative for CNS involvement; the lumbar puncture must be completed within 28 days prior to registration. Patients with CNS1 or CNS2 are eligible; however patients with CNS3 are not eligible
  • Note that the patients may receive intrathecal chemotherapy with the initial lumbar puncture. This may count as the first dose of intrathecal therapy required as part of the study
  • Prior nelarabine therapy is not required. In addition, for patients ≥ 18 years of age who received nelarabine during initial induction or post-remission treatment are eligible only if the physician does not feel they would benefit from other, multi-agent chemotherapy
  • Patients must not have had chemotherapy or investigational agents within 14 days prior to registration except for corticosteroids, oral 6-mercaptopurine, oral methotrexate, vincristine, intrathecal chemotherapy, or hydroxyurea. For participants who have received radiation therapy, at least 7 days must have elapsed from the end of radiation prior to registration and participants must not currently be experiencing toxicities from radiation therapy
  • Patients must not have undergone allogeneic hematopoietic transplant within 90 days prior to registration
  • Patients must have no evidence of active \>= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD. Patients must have no history of extensive GVHD of any severity within 90 days prior to registration. Patients who are post-transplant must be off calcineurin inhibitors for at least 21 days to be eligible. Extensive GVHD is defined as 1) generalized skin involvement or 2) localized skin involvement and/or hepatic dysfunction plus liver histology or cirrhosis or involvement of eye or minor salivary organ or oral mucosa or any other target organ
  • Patients must be \>= 12 years of age
  • Patients ≥ 16 years of age must have a Zubrod Performance Status of 0-3. Patients \< 16 years of age must have a Lansky score of ≥ 50
  • Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) within 14 days prior to registration
  • Patients ≥ 18 years of age must have creatinine clearance \> 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation
  • Patients 12-17 years of age must have adequate renal function within 14 days prior to registration defined as serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) according to age or a calculated estimated glomerular filtration rate (eGFR) (based on Schwartz formula) or radioisotope glomerular filtration rate (GFR) ≥ 50ml/min/1.73 m\^2
  • Patients must have direct bilirubin =\< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration
  • Patients must have alanine aminotransferase (ALT) =\< 3.0 x institutional upper limit of normal (ULN) or =\< 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration
  • Prothrombin time (PT)/partial thromboplastin time (PTT)/ fibrinogen (as clinically indicated for example but not limited to history of bleeding or active bleeding, concern for disseminated intravascular coagulation) (within 14 days prior to registration to obtain baseline measurements)
  • From metabolic panel (comprehensive or basic): sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements)
  • Patients must be able to safely discontinue use of strong inhibitors/inducers of CYP3A4 or PgP-g-p and must be able to safely discontinue use of naproxen for 48 hours before and after each dose of OBI-3424
  • Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test within 6 months prior to registration. (HIV viral load testing is required only for patients with known HIV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
  • Patients with evidence of chronic hepatitis B virus (HBV) infection may be eligible provided that they have an undetectable HBV viral load within 28 days prior to registration. Patients may be currently receiving HBV treatment. (HBV viral load testing is required only for patients with known HBV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
  • Patients with known history of hepatitis C virus (HCV) infection may be eligible provided that they have an undetectable HCV viral load within in 28 days prior to registration. Patients may be currently receiving treatment. (HCV viral load testing is required only for patients with known HCV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
  • Patients must not have a known history of prolonged QT interval by Fridericia (QTcF) (interval \> 450 msec for males; \> 470 msec for females). Patients that had transient prolongation of QTc secondary to medications or electrolyte abnormalities are not excluded if the QTc normalized and remain within acceptable QTcF range (interval \> 450 msec for males; \> 470 msec for females). Additionally, suspected medications should be no longer required or used, and electrolyte abnormalities must have normalized
  • Patients must not be pregnant or nursing due to the teratogenic potential of the drug used on this study. Females of reproductive potential must have a negative serum pregnancy test within 14 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method during and up to 6 months after treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must not have other active malignancies for which they have received treatments within 6 months prior to registration excluding localized malignancies that do not require systemic treatment
  • Patients must agree to have bone marrow and blood specimens submitted for MRD testing
  • Patients must be offered the opportunity to participate in specimen banking. With patient consent, residuals from specimens submitted will be retained and banked for future research
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with fedral, local, institutional and Central Institutional Review Board (CIRB) guidelines unless they are unable to provide consent based on age (\< 18 years) or based on impaired decision-making capabilities. For patients \< 18 years of age or with impaired decision making capabilities, parents or other legally authorized representatives must sign and give informed consent on behalf of study participants in accordance with applicable federal, local, institutional and CIRB regulations
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • This trial will use a slot reservation system to enroll the Phase I portion of the study. Patients planning to enroll at this phase of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (163)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Mary Greeley Medical Center
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AmesUnited StatesUnknown status
McFarland Clinic - Ames
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AmesUnited StatesUnknown status
PCR Oncology
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Arroyo GrandeUnited StatesUnknown status
Children's Healthcare of Atlanta - Arthur M Blank Hospital
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AtlantaUnited StatesUnknown status
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
Augusta University Medical Center
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AugustaUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Dell Children's Medical Center of Central Texas
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AustinUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesUnknown status
LSU Health Baton Rouge-North Clinic
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Baton RougeUnited StatesUnknown status
Our Lady of the Lake Physician Group
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Baton RougeUnited StatesUnknown status
Bronson Battle Creek
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Battle CreekUnited StatesUnknown status
Overlake Medical Center
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BellevueUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesUnknown status
McFarland Clinic - Boone
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BooneUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
Fairview Ridges Hospital
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BurnsvilleUnited StatesUnknown status
Minnesota Oncology - Burnsville
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BurnsvilleUnited StatesUnknown status
Loyola Center for Health at Burr Ridge
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Burr RidgeUnited StatesUnknown status
Cambridge Medical Center
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CambridgeUnited StatesUnknown status
Carson Tahoe Regional Medical Center
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Carson CityUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Prisma Health Richland Hospital
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ColumbiaUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
El Paso Children's Hospital
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El PasoUnited StatesUnknown status
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesUnknown status
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesUnknown status
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesUnknown status
Unity Hospital
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FridleyUnited StatesUnknown status
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Las Vegas Urology - Pebble
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HendersonUnited StatesUnknown status
Las Vegas Cancer Center-Henderson
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HendersonUnited StatesUnknown status
Urology Specialists of Nevada - Green Valley
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HendersonUnited StatesUnknown status
OptumCare Cancer Care at Seven Hills
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HendersonUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada-Horizon Ridge
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HendersonUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada-Southeast Henderson
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HendersonUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Henderson
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HendersonUnited StatesUnknown status
GenesisCare USA - Henderson
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HendersonUnited StatesUnknown status
Las Vegas Urology - Green Valley
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HendersonUnited StatesUnknown status
Cancer and Blood Specialists-Henderson
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HendersonUnited StatesUnknown status
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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HollywoodUnited StatesUnknown status
Loyola Medicine Homer Glen
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Homer GlenUnited StatesUnknown status
McFarland Clinic - Jefferson
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JeffersonUnited StatesUnknown status
West Michigan Cancer Center
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KalamazooUnited StatesUnknown status
Bronson Methodist Hospital
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KalamazooUnited StatesUnknown status
Beacon Kalamazoo Cancer Center
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KalamazooUnited StatesUnknown status
Beacon Kalamazoo
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KalamazooUnited StatesUnknown status
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesUnknown status
Kingman Regional Medical Center
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KingmanUnited StatesUnknown status
Gundersen Lutheran Medical Center
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La CrosseUnited StatesUnknown status
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesUnknown status
Las Vegas Urology - Smoke Ranch
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Las VegasUnited StatesUnknown status
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
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Las VegasUnited StatesUnknown status
Radiation Oncology Centers of Nevada Central
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada-Summerlin
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Central Valley
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Las VegasUnited StatesUnknown status
Las Vegas Prostate Cancer Center
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Las VegasUnited StatesUnknown status
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Sunset
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Las VegasUnited StatesUnknown status
Urology Specialists of Nevada - Southwest
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Las VegasUnited StatesUnknown status
GenesisCare USA - Fort Apache
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at Charleston
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Las VegasUnited StatesUnknown status
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
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Las VegasUnited StatesUnknown status
Urology Specialists of Nevada - Northwest
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at MountainView
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Town Center
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Las VegasUnited StatesUnknown status
Las Vegas Cancer Center-Medical Center
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Northwest
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Las VegasUnited StatesUnknown status
Hope Cancer Care of Nevada
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Las VegasUnited StatesUnknown status
GenesisCare USA - Vegas Tenaya
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Las VegasUnited StatesUnknown status
GenesisCare USA - Las Vegas
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Las VegasUnited StatesUnknown status
Ann M Wierman MD LTD
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Las VegasUnited StatesUnknown status
University Medical Center of Southern Nevada
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
Radiation Oncology Centers of Nevada Southeast
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Las VegasUnited StatesUnknown status
Urology Specialists of Nevada - Central
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Las VegasUnited StatesUnknown status
Sunrise Hospital and Medical Center
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at Fort Apache
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Cathedral Rock
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Las VegasUnited StatesUnknown status
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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Las VegasUnited StatesUnknown status
Summerlin Hospital Medical Center
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Las VegasUnited StatesUnknown status
University Cancer Center
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Pecos
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Las VegasUnited StatesUnknown status
HealthCare Partners Medical Group Oncology/Hematology-San Martin
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Las VegasUnited StatesUnknown status
Desert West Surgery
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Las VegasUnited StatesUnknown status
Arkansas Children's Hospital
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Little RockUnited StatesUnknown status
Loma Linda University Medical Center
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Loma LindaUnited StatesUnknown status
Norton Children's Hospital
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LouisvilleUnited StatesUnknown status
Fairview Clinics and Surgery Center Maple Grove
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Maple GroveUnited StatesUnknown status
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesUnknown status
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesUnknown status
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Melrose ParkUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Hennepin County Medical Center
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MinneapolisUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
Health Partners Inc
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MinneapolisUnited StatesUnknown status
Monticello Cancer Center
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MonticelloUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Trinity Health Muskegon Hospital
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MuskegonUnited StatesUnknown status
The Children's Hospital at TriStar Centennial
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NashvilleUnited StatesUnknown status
UC Comprehensive Cancer Center at Silver Cross
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New LenoxUnited StatesUnknown status
Cancer Center of Western Wisconsin
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New RichmondUnited StatesUnknown status
New Ulm Medical Center
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New UlmUnited StatesUnknown status
Corewell Health Lakeland Hospitals - Niles Hospital
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NilesUnited StatesUnknown status
Children's Hospital of The King's Daughters
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NorfolkUnited StatesUnknown status
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Norton ShoresUnited StatesUnknown status
Children's Hospital and Medical Center of Omaha
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OmahaUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited StatesUnknown status
University of Chicago Medicine-Orland Park
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Orland ParkUnited StatesUnknown status
Hope Cancer Care of Nevada-Pahrump
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PahrumpUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Fairview Northland Medical Center
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PrincetonUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
Corewell Health Reed City Hospital
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Reed CityUnited StatesUnknown status
Saint Mary's Regional Medical Center
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RenoUnited StatesUnknown status
Renown Regional Medical Center
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RenoUnited StatesUnknown status
Radiation Oncology Associates
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RenoUnited StatesUnknown status
Valley Medical Center
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RentonUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesUnknown status
North Memorial Medical Health Center
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RobbinsdaleUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesUnknown status
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Saint JosephUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
Methodist Children's Hospital of South Texas
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San AntonioUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
Saint Francis Regional Medical Center
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ShakopeeUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Lakeview Hospital
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StillwaterUnited StatesUnknown status
Johns Hopkins All Children's Hospital
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St. PetersburgUnited StatesUnknown status
Munson Medical Center
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Traverse CityUnited StatesUnknown status
Ridgeview Medical Center
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WaconiaUnited StatesUnknown status
University of Cincinnati Cancer Center-West Chester
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West ChesterUnited StatesUnknown status
Rice Memorial Hospital
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WillmarUnited StatesUnknown status
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesUnknown status
Minnesota Oncology Hematology PA-Woodbury
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WoodburyUnited StatesUnknown status
Fairview Lakes Medical Center
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WyomingUnited StatesUnknown status
University of Michigan Health - West
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WyomingUnited StatesUnknown status
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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YakimaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.