Study to Test OBI-3424 in Patients with Relapsed or Hard-to-Treat T-Cell Acute Lymphoblastic Leukemia (T-ALL)

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04315324

Provider View

This clinical trial is testing a new drug, OBI-3424, to see if it can help treat T-cell acute lymphoblastic leukemia (T-ALL) that has returned or is not responding to treatment. The study aims to find out how well the drug works and what side effects it might have.

Patient Parameters

Program Overview

This study is exploring the effectiveness of a new chemotherapy drug, OBI-3424, in treating patients with T-cell acute lymphoblastic leukemia (T-ALL) that has either come back after treatment or is not responding to current treatments. Chemotherapy drugs like OBI-3424 work by stopping cancer cells from growing, dividing, or spreading. The goal is to see if OBI-3424 can reduce the amount of leukemia in the body.

Description

The main goal of this study is to see how well OBI-3424 works in achieving complete remission (CR) or CR with incomplete count recovery (CRi) in patients with relapsed or refractory T-ALL. Researchers will also look at the side effects of OBI-3424 and how often they occur. Additionally, the study will measure how long patients live without the disease getting worse (event-free survival), how long they stay in remission (relapse-free survival), and their overall survival.

The study will also explore the presence of minimal residual disease (MRD) in patients who achieve CR or CRi, and assess the levels of a specific protein, AKR1C3, in patients. Researchers will evaluate if there is a link between AKR1C3 levels and the response to OBI-3424, as well as the achievement of MRD-negative remission and relapse from remission. Specimens will be collected for future research.

Participants will receive OBI-3424 through an IV over 30 minutes on days 1 and 8 of each 21-day cycle, for up to 17 cycles, unless the disease progresses or side effects become unacceptable. After completing the treatment, patients will have follow-up visits every month for the first year, every two months for the second year, every three months for the third year, and then every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).
  • Must have evidence of leukemia in the blood or bone marrow, with at least 5% lymphoblasts.
  • Must have tried standard chemotherapy treatments and either not responded or relapsed.
  • Must not have central nervous system disease based on recent tests.
  • Must be 18 years or older.
  • Must have a performance status score of 0-3, indicating varying levels of activity.
  • Must have adequate kidney and liver function based on specific blood tests.
  • Must agree to provide bone marrow and blood samples for testing.
  • Must be informed about the study and sign a consent form.

Exclusion Criteria

  • Must not have had chemotherapy or investigational drugs within 14 days before joining the study, except for certain allowed medications.
  • Must not have had a bone marrow transplant within 90 days before joining the study.
  • Must not have uncontrolled infections within 14 days before joining the study.
  • Must not be pregnant or nursing, and must agree to use effective contraception during and after treatment.
  • Must not have other active cancers that required treatment within the last 6 months.

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