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

Conditions

• Recurrent T Acute Lymphoblastic Leukemia
• Refractory T Acute Lymphoblastic Leukemia
• Refractory T Lymphoblastic Lymphoma
• T Lymphoblastic Lymphoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AKR1C3-activated Prodrug AST-3424 — DRUG
  Given IV
• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood and CSF sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspirate
• Computed Tomography — PROCEDURE
  Undergo CT scan

Study Details

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 Dates

Start date

Feb 8, 2021

Status verified

Aug 2025

Primary completion

Aug 1, 2026

Completion

Aug 1, 2028

Study Design

Enrollment

67 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (AKR1C3-activated prodrug OBI-3424)
  Patients receive AKR1C3-activated prodrug OBI-3424 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not achieved a PR by the 4th cycle of treatment are removed from the study (unless clinically benefitting in the opinion of the treating investigator).Patients undergo blood sample collection during screening and CSF sample collection on study. Patients also undergo bone marrow aspirate or core biopsy and may undergo CT scan throughout the study.

Primary Outcome Measure

Maximum tolerated dose (MTD) (Phase I) [ Time Frame: Up to 21 days ]

Locations (163)

Find similar trials in Birmingham, AL

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