Study on Low-Intensity Chemotherapy and Venetoclax for Treating Relapsed or Hard-to-Treat B- or T-Cell Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03808610

Provider View

This clinical trial is exploring the use of venetoclax combined with low-intensity chemotherapy to treat patients with B- or T-cell acute lymphoblastic leukemia that has returned or not responded to previous treatments. The study aims to find the best dose and evaluate how well this combination works.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with B- or T-cell acute lymphoblastic leukemia (ALL) that has either come back or not responded to previous treatments. The treatment combines venetoclax, a drug that may stop cancer cells from growing, with low-intensity chemotherapy. The goal is to find the safest and most effective dose of venetoclax and to see how well this combination can help control the leukemia.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of venetoclax when used with low-intensity chemotherapy. In Phase II, they will evaluate how well this treatment works in shrinking the cancer and improving patient outcomes.

Patients will receive venetoclax daily for 21 days, along with various chemotherapy drugs given at different times during the treatment cycles. The chemotherapy drugs include vincristine, cyclophosphamide, dexamethasone, methotrexate, and cytarabine. Some patients may also receive rituximab, depending on their doctor's decision.

For patients with T-cell ALL, additional drugs like nelarabine and pegaspargase may be given after the initial treatment cycles. Maintenance therapy may include prednisone, vincristine, and venetoclax for up to two years, depending on the patient's response and tolerance.

After completing the study treatment, patients will be monitored for 30 days and then every three months to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with relapsed or hard-to-treat B- or T-cell ALL.
  • Adults aged 60 or older with newly diagnosed B- or T-cell ALL, or younger patients who cannot undergo intensive chemotherapy.
  • Good overall health with a performance status of 3 or lower.
  • Adequate liver and kidney function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • All participants must agree to use effective birth control during the study and for four months after treatment.
  • Must provide signed informed consent to participate in the study.

Exclusion Criteria

  • Patients with Philadelphia chromosome-positive ALL or Burkitt leukemia.
  • Patients eligible for intensive chemotherapy (for newly diagnosed patients only).
  • Active serious infections not controlled by antibiotics.
  • Known leukemia in the central nervous system requiring radiation.
  • Active graft-versus-host disease (GVHD).
  • Active secondary cancer that may shorten life expectancy to less than one year.
  • Known hepatitis B or C infection, or HIV.
  • Severe heart failure or low heart function.
  • Recent use of certain medications that affect venetoclax or blood clotting.
  • Consumption of grapefruit, Seville oranges, or star fruit within three days before starting venetoclax.
  • Previous treatment with navitoclax.
  • Recent treatment with other investigational or chemotherapy agents, unless fully recovered from side effects.
  • Pregnant or breastfeeding women, or those not willing to use contraception.
  • History of significant bleeding disorders unrelated to cancer.

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