RecruitingPhase 2NCT04626791

Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma


Sponsor

Academic and Community Cancer Research United

Enrollment

45 participants

Start Date

Aug 3, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new first-line treatment combination for mantle cell lymphoma (a rare type of blood cancer) in patients who are healthy enough to eventually receive a stem cell transplant. The regimen combines a modified chemotherapy (VR-CAP) with a targeted drug called acalabrutinib, which blocks a protein that helps cancer cells grow. **You may be eligible if...** - You are 18–75 years old - You have newly diagnosed mantle cell lymphoma that has not been treated yet - Your lymphoma needs treatment and your doctor believes you could eventually qualify for a stem cell transplant - You have measurable disease on scans - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have had prior treatment for mantle cell lymphoma - You are pregnant or breastfeeding - You have severe heart, liver, or kidney problems - You are taking blood thinners or medications that interact with the study drugs - You have active HIV or hepatitis B/C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Given PO

DRUGBortezomib

Given SC

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given IV

DRUGDoxorubicin Hydrochloride

Given IV

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

BIOLOGICALRituximab and Hyaluronidase Human

Given IV


Locations(7)

Ochsner NCI Community Oncology Research Program

New Orleans, Louisiana, United States

Metropolitan-Mount Sinai Medical Center

Minneapolis, Minnesota, United States

Mount Sinai Hospital

New York, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04626791


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