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

Recruiting now · Phase 1/Phase 2

Conditions studied: Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia, Refractory T Lymphoblastic Lymphoma, T Lymphoblastic Lymphoma

In brief

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.

Key facts

Study ID

NCT04315324

Run by

SWOG Cancer Research Network

People needed

67

Starts

2021-02-08

Expected to finish

2028-08-01

Last updated by the study team

2025-08-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States (enrolling)
• McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States (enrolling)
• Kingman Regional Medical Center — Kingman, Arizona, United States (enrolling)
• McFarland Clinic - Boone — Boone, Iowa, United States (enrolling)
• McFarland Clinic - Jefferson — Jefferson, Iowa, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• PCR Oncology — Arroyo Grande, California, United States (enrolling)
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• McFarland Clinic - Ames — Ames, Iowa, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States (enrolling)
• Augusta University Medical Center — Augusta, Georgia, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Illinois — Chicago, Illinois, United States (enrolling)
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (enrolling)
• Mary Greeley Medical Center — Ames, Iowa, United States (enrolling)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• Loma Linda University Medical Center — Loma Linda, California, United States (enrolling)
• Norton Children's Hospital — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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