Study on Acalabrutinib and Rituximab for Treating Untreated Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04765111

Provider View

This clinical trial is exploring the effects and safety of combining acalabrutinib and rituximab to treat elderly patients with mantle cell lymphoma who have not received any prior treatment.

Patient Parameters

Program Overview

This study aims to understand how well the combination of acalabrutinib and rituximab works in treating mantle cell lymphoma (MCL) in elderly patients who have not been treated before. Acalabrutinib may help stop cancer cells from growing by blocking certain enzymes, while rituximab is an antibody that targets a protein on B-cells to kill cancer cells. The trial will assess the effectiveness and safety of this combination in controlling MCL.

Description

The main goals of this study are to see how effective the combination of acalabrutinib and rituximab is in achieving complete remission in elderly patients with newly diagnosed mantle cell lymphoma (MCL) and to evaluate the safety of this treatment. Researchers will also look at overall response rates, how long patients live without the disease getting worse, and overall survival. They will use advanced techniques to study the cancer's genetic makeup and how it changes over time.

Participants will take acalabrutinib pills twice a day in 28-day cycles, and receive rituximab infusions on specific days during the first cycle and then once every cycle for up to 24 months or until the cancer is under control. After treatment, patients will have follow-up visits to monitor their health and the treatment's long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Age 65 or older with newly diagnosed mantle cell lymphoma (MCL) and no previous treatment.
  • Confirmed diagnosis of MCL with specific genetic markers.
  • Good heart health and clearance from a cardiologist if needed.
  • Able to swallow pills and participate in study procedures.
  • Measurable disease by scans.
  • Good overall health with a performance status of 0, 1, or 2.
  • Adequate blood counts and organ function.
  • No other active cancers, except for certain skin cancers or cancers in remission.
  • Willing to use effective birth control during and after treatment.

Exclusion Criteria

  • Previous treatment for MCL or with acalabrutinib.
  • Other active cancers or history of certain serious conditions.
  • Central nervous system involvement with MCL.
  • Pregnant or breastfeeding women.
  • Difficulty swallowing pills or significant digestive issues.
  • Allergies to study drugs.
  • Participation in another clinical trial.
  • Recent live vaccinations.
  • Active infections or certain viral infections.
  • Recent major surgery or certain heart conditions.
  • Use of certain medications that interact with the study drugs.
  • Uncontrolled high blood pressure or other serious medical conditions.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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