Venetoclax and Chemotherapy as Initial Treatment for Older Patients and Those with Relapsed or Hard-to-Treat Acute Lymphoblastic Leukemia (ALL)

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03319901

Provider View

This clinical trial is exploring the use of Venetoclax, combined with standard chemotherapy, as a potential treatment for Acute Lymphoblastic Leukemia (ALL) in older patients and those whose cancer has returned or is difficult to treat.

Patient Parameters

Program Overview

The study is testing a drug called Venetoclax along with a standard chemotherapy regimen to see if it can effectively treat Acute Lymphoblastic Leukemia (ALL). The chemotherapy includes drugs like cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine. Venetoclax works by blocking a protein that helps cancer cells survive, potentially leading to their death. This trial aims to find the safest and most effective dose of Venetoclax when used with chemotherapy.

Description

This is a Phase I clinical trial, which means it is focused on testing the safety of Venetoclax and its combination with chemotherapy, as well as determining the best dose to use in future studies. Venetoclax is not yet approved by the FDA for treating this specific type of leukemia, but it is approved for other uses. The drug works by targeting a protein called Bcl-2, which is important for keeping cancer cells alive. By blocking Bcl-2, Venetoclax may help kill cancer cells and shrink tumors. Participants in this study will first receive Venetoclax alone, followed by a combination of Venetoclax and standard chemotherapy. The goal is to understand how this combination affects the disease and to identify the safest and most effective dose.

Eligibility Criteria

Inclusion Criteria

  • Have not been treated before for acute lymphoblastic leukemia (ALL) and have at least 20% cancerous cells in the bone marrow.
  • Be 60 years or older.

OR

  • Have ALL that has returned or is not responding to treatment, with at least 5% cancerous cells in the bone marrow.
  • Be 18 years or older.
  • Be in good general health, with a performance status score of 0 to 2.
  • Have adequate organ function, including:
    • Normal bilirubin levels, unless you have Gilbert's disease.
    • Normal liver enzyme levels, unless due to the disease.
    • Good kidney function.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during the study and for 30 days after.
  • Men with partners of childbearing age must agree to use effective birth control during the study and for 30 days after.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Have a specific type of ALL called Ph-positive ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma.
  • Are pregnant or breastfeeding.
  • Have an uncontrolled infection.
  • Have hepatitis B or C, or are HIV positive.
  • Have had major surgery or radiation therapy within the last 4 weeks.
  • Have had chemotherapy or other investigational therapy within the last 14 days, except for certain medications.
  • Have untreated or symptomatic cancer spread to the brain or spinal cord.
  • Have active heart disease or a low heart function.
  • Have another untreated or active cancer.
  • Are taking warfarin or certain other medications that affect Venetoclax.
  • Have consumed grapefruit or similar fruits within 3 days of starting Venetoclax.
  • Have been treated with Venetoclax before.
  • Have a condition that affects the absorption of medications.
  • Have any other severe medical or psychiatric condition that could interfere with the study.

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