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

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.

Trial Details

NCT ID
NCT04315324
Phase
PHASE1 / PHASE2
Sponsor
SWOG Cancer Research Network
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • AKR1C3-activated Prodrug AST-3424
  • Biopsy Procedure
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Computed Tomography
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Kingman, Arizona, United States|35.18944,-114.05301
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Arroyo Grande, California, United States|35.11859,-120.59073
  • Loma Linda, California, United States|34.04835,-117.26115

Key Eligibility Criteria

  • Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) class…
  • Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have \>= 5% lymphoblasts in the peripheral bl…
  • Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients \< 18 years of age must hav…
  • A standard chemotherapy induction regimen is defined as any program of treatment that includes:

For full eligibility, visit ClinicalTrials.gov.

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