Study on Venetoclax and Vincristine Liposomal for Treating Patients with Relapsed or Hard-to-Treat T-cell or B-cell Acute Lymphoblastic Leukemia

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03504644

Provider View

This clinical trial is testing a combination of two drugs, venetoclax and vincristine liposomal, to see if they can effectively treat patients with T-cell or B-cell acute lymphoblastic leukemia that has returned or is not responding to treatment.

Patient Parameters

Program Overview

This study is exploring the use of two drugs, venetoclax and vincristine liposomal, to treat patients with T-cell or B-cell acute lymphoblastic leukemia (ALL) that has come back or is not responding to treatment. Venetoclax works by blocking certain enzymes that cancer cells need to grow, while vincristine liposomal is a chemotherapy drug that stops cancer cells from growing and spreading. The study aims to find the best dose of venetoclax and to see how well the combination of these drugs works in treating ALL.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of venetoclax when used with vincristine liposomal in patients with relapsed or refractory T-cell and B-cell acute lymphoblastic leukemia (ALL). They will also assess the safety and any side effects of this combination. In Phase II, the study will evaluate how well this treatment can induce complete remission by day 70 in these patients.

Secondary goals include assessing how long patients live without the disease getting worse, overall survival, and any side effects after the treatment. The study will also explore whether certain genetic markers or characteristics of the leukemia can predict how well patients respond to the treatment.

Participants will take venetoclax by mouth daily for two courses, each lasting 42 days. They will also receive vincristine liposomal through an IV once a week for four weeks, starting on day 14 of the first course. After completing the treatment, patients will be monitored every six months for five years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Have T-cell or B-cell acute lymphoblastic leukemia (ALL) that has returned or is not responding to treatment.
  • Be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate liver function and a white blood cell count below a certain level.
  • Women must not be pregnant or breastfeeding, and all participants must agree to use effective contraception during the study and for 30 days after the last dose of venetoclax.
  • No history of other cancers unless they have been treated and disease-free for at least five years.
  • No active central nervous system leukemia.
  • No recent chemotherapy within two weeks before enrollment, except for certain maintenance treatments.
  • May have had a stem cell transplant at least 90 days before enrollment, with no active graft versus host disease.
  • HIV-positive patients are allowed if they have a stable condition and a CD4 count of 400 or higher.
  • No severe heart conditions or other serious medical or psychiatric illnesses that could interfere with the study.
  • Not participating in another clinical trial or taking experimental medications within 21 days before enrollment.
  • No recent use of certain medications that could interfere with the study drugs.
  • No severe nerve damage (grade 3 or higher peripheral neuropathy).

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