Study on Acalabrutinib, Venetoclax, and Rituximab for Untreated Mantle Cell Lymphoma

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT05951959

This clinical trial is testing a new combination of drugs—Acalabrutinib, Venetoclax, and Rituximab—to see if they can effectively treat patients with newly diagnosed Mantle Cell Lymphoma (MCL). The study will also explore if patients who respond well can safely stop treatment and what happens if the cancer returns.

Patient Parameters

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Program Overview

The study, called TrAVeRse, is looking at how well a combination of three drugs—Acalabrutinib, Venetoclax, and Rituximab—works for people with Mantle Cell Lymphoma (MCL) who have not received treatment before. The main goal is to see if this combination can lead to a complete response, meaning no detectable cancer, after 13 cycles of treatment. If patients achieve this, they will either continue taking Acalabrutinib or be monitored without treatment to see if the cancer returns. If it does, they may start taking Acalabrutinib again.

Description

Mantle Cell Lymphoma (MCL) is a type of cancer that usually requires treatment soon after diagnosis. This study is testing a new treatment approach that does not involve traditional chemotherapy. Instead, it uses a combination of three drugs: Acalabrutinib, Venetoclax, and Rituximab. These drugs work in different ways to target cancer cells.

Participants in the study will take these drugs over 13 cycles, with each cycle lasting 28 days. Acalabrutinib is taken twice daily, Venetoclax once daily, and Rituximab is given as an infusion once per cycle. After completing the 13 cycles, doctors will check if the cancer is undetectable. If it is, participants will either continue taking Acalabrutinib or be observed without treatment. If the cancer returns during observation, they can start taking Acalabrutinib again.

The study will last about 67 months and aims to find out how effective this treatment is, how long it keeps the cancer away, and how safe it is for patients.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) with specific genetic markers.
Be in clinical stage II, III, or IV and need treatment.
Have at least one measurable tumor.
Be in good overall health, with a performance status score of 0, 1, or 2.
Provide a tumor sample for genetic testing.
Have adequate organ and bone marrow function.
Agree to use effective birth control during the study and for a specified time after the last dose of the study drugs.
Be able to give informed consent to participate in the study.

Exclusion Criteria

Have active cancer in the central nervous system.
Have another active cancer requiring treatment, except for certain skin cancers or cancers that have not returned for at least 2 years.
Have severe or life-threatening medical conditions that could interfere with the study.
Have significant heart disease or uncontrolled infections.
Have active HIV or hepatitis B or C infections.
Have a history of certain brain conditions or bleeding disorders.
Be pregnant or breastfeeding.
Have had previous treatment for MCL, except for certain types of radiation therapy.
Be taking medications that could interfere with the study drugs.
Have participated in another clinical trial within 30 days before starting this study.
Be unable to comply with study procedures.

Locations

FACILITY	ZIP	CITY	STATE
Research Site	07601	Hackensack	New Jersey
Research Site	11794	Stony Brook	New York
Research Site	44195	Cleveland	Ohio
Research Site	19104	Philadelphia	Pennsylvania
Research Site	77030	Houston	Texas

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