Study on Venetoclax with Ibrutinib or Acalabrutinib for High-Risk Chronic Lymphocytic Leukemia (CLL)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03128879

Provider View

This clinical trial is testing a combination of the drug venetoclax with either ibrutinib or acalabrutinib in patients with high-risk chronic lymphocytic leukemia (CLL) who have been on ibrutinib or acalabrutinib for at least 12 months.

Patient Parameters

Program Overview

The study aims to see if adding venetoclax to ongoing treatment with ibrutinib or acalabrutinib can help control high-risk CLL better. High-risk CLL includes certain genetic features that make the disease more challenging to treat. Participants will take venetoclax along with their current medication for up to 24 cycles, each lasting 4 weeks, unless the disease progresses or side effects become unacceptable.

Description

The main goal of this study is to find out if adding venetoclax to ibrutinib or acalabrutinib can help patients with high-risk CLL achieve a state where no cancer cells are detectable in the bone marrow. This is called MRD-negativity. The study will also look at how many patients achieve complete remission (CR) or partial remission (CRi) at different times during the treatment, and how long it takes to reach the best response.

Secondary goals include assessing the safety of the drug combination, how long patients live without the disease getting worse, and overall survival rates. Participants will take venetoclax daily, along with either ibrutinib or acalabrutinib, for up to 24 cycles. Each cycle lasts 4 weeks. After finishing the treatment, patients will have follow-up visits every 6 to 12 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk CLL, which includes specific genetic features like del(17p) or TP53 mutation.
  • Have been on ibrutinib or acalabrutinib for at least 12 months and still have measurable CLL.
  • Be 18 years or older.
  • Have a performance status that allows for daily activities with some restrictions.
  • Have adequate kidney and liver function based on blood tests.
  • Have sufficient blood cell counts and heart function.
  • Women of childbearing potential 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 potential must agree to use effective contraception during the study and for 30 days after.
  • Be able to provide informed consent and follow study requirements.

Exclusion Criteria

  • Have a different type of cancer that requires treatment, except for certain skin cancers or other cancers treated with curative intent.
  • Have had major surgery or other cancer treatments within 3 weeks before starting the study.
  • Have uncontrolled infections or bleeding issues.
  • Be pregnant or breastfeeding.
  • Have active hepatitis B or C, or HIV.
  • Have uncontrolled autoimmune conditions requiring high-dose steroids.
  • Have taken other investigational drugs for CLL within 21 days before starting venetoclax.
  • Be using certain medications that interact with venetoclax, like strong CYP3A inhibitors or inducers.
  • Have a condition that affects the absorption of oral medications.

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