Study on Venetoclax and Acalabrutinib for Treating Patients with Relapsed or Returning Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03946878

Provider View

This clinical trial is testing how well the combination of venetoclax and acalabrutinib works in patients with mantle cell lymphoma that has not responded to previous treatments or has returned. The study aims to see if these drugs can effectively kill cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring the effectiveness of two drugs, venetoclax and acalabrutinib, in treating patients with mantle cell lymphoma (MCL) that has either come back or not responded to previous treatments. Venetoclax works by blocking a mechanism that cancer cells use to survive, while acalabrutinib stops cancer cells from growing by blocking certain enzymes. By using these drugs together, researchers hope to kill more cancer cells and improve treatment results for patients with MCL.

Description

The main goal of this study is to evaluate how well the combination of venetoclax and acalabrutinib works in patients with previously treated mantle cell lymphoma that has returned or not responded to treatment. Researchers will look at how long patients respond to the treatment, how long they live without the disease getting worse, and overall survival rates. They will also assess the safety and side effects of the drug combination.

The study involves taking venetoclax and acalabrutinib orally. Patients will take acalabrutinib twice daily and start venetoclax from the second cycle. Each treatment cycle lasts 28 days and will continue as long as the disease does not progress and side effects are manageable.

After finishing the treatment, patients will have follow-up visits within 30 days, then every 4 months for 2 years, every 6 months for the next 2 years, and annually after that.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of mantle cell lymphoma that has returned or not responded to at least one previous treatment.
  • Able to understand the study and provide informed consent.
  • Willing to participate in all study evaluations and procedures.
  • Aged 18 years or older.
  • Have measurable disease as defined by specific medical criteria.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Meet specific blood count and organ function criteria.
  • No other active cancers, except for certain skin cancers or other cancers in remission.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Men must agree not to donate sperm during the study.

Exclusion Criteria

  • Previous treatment with acalabrutinib or investigational drugs within 30 days before the study.
  • History of other cancers that could interfere with the study.
  • Serious medical conditions that pose a risk to the patient.
  • Pregnant or breastfeeding women.
  • Known HIV infection.
  • Uncontrolled autoimmune conditions or significant infections.
  • Active hepatitis B or C infection.
  • Central nervous system disease with serious significance.
  • Conditions affecting the digestive system that could interfere with drug absorption.
  • Major surgery within 30 days before the study.
  • Known bleeding disorders or recent stroke.
  • Use of certain medications that could interfere with the study drugs.
  • Vaccination with live vaccines within 4 weeks before the study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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