Study on Modified VR-CAP and Acalabrutinib as First Treatment for Transplant-Eligible Patients with Mantle Cell Lymphoma

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04626791

Provider View

This clinical trial is exploring how well a combination of drugs, including modified VR-CAP and acalabrutinib, works as the first treatment for patients with mantle cell lymphoma who are eligible for a stem cell transplant.

Patient Parameters

Program Overview

This study is testing a new combination of drugs to see if it can better treat mantle cell lymphoma in patients who are eligible for a stem cell transplant. The treatment includes a mix of chemotherapy drugs and a targeted therapy called acalabrutinib. These drugs work together to stop cancer cells from growing and spreading. The goal is to find out if this combination is more effective than the usual treatment.

Description

The main goal of this study is to see how many patients achieve a complete response to the treatment, meaning no signs of cancer are found after therapy. Researchers will also look at the safety of the treatment, how many patients can proceed to a stem cell transplant, and how long patients live without the cancer coming back.

Patients will receive the treatment in cycles, with each cycle lasting 21 days. In some cycles, patients will take acalabrutinib and a combination of other drugs, including bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone. In other cycles, they will take acalabrutinib, rituximab, and cytarabine. This treatment will continue for up to six cycles unless the cancer progresses or side effects become too severe.

After finishing the treatment, patients will have follow-up visits every six months for up to two years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 75 years.
  • Have not received any prior treatment for mantle cell lymphoma.
  • Have mantle cell lymphoma that requires treatment and are eligible for a stem cell transplant.
  • Have a confirmed diagnosis of mantle cell lymphoma.
  • Have at least one measurable tumor as detected by scans.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree to use barrier contraception during and after the study.
  • Be willing to provide informed consent and comply with study requirements.

Exclusion Criteria

  • Have received any prior systemic treatment for mantle cell lymphoma.
  • Have significant nerve pain or damage.
  • Have previously been treated with bortezomib or a BTK inhibitor.
  • Have certain blood disorders or active bleeding issues.
  • Have had a stroke or brain bleed within the last six months.
  • Require certain medications that interact with the study drugs.
  • Have severe allergies to any of the study drugs.
  • Have active infections or uncontrolled hepatitis B or C.
  • Have other serious health conditions that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Have difficulty swallowing pills or have significant digestive issues.
  • Have had major surgery recently or are participating in another clinical trial.

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