Study on Acalabrutinib, Lenalidomide, and Rituximab for Patients with Untreated Mantle Cell Lymphoma

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40

ClinicalTrials ID:NCT03863184

This clinical trial is testing a combination of three drugs—Acalabrutinib, Lenalidomide, and Rituximab (ALR)—to see if they are safe and effective for treating patients with mantle cell lymphoma who have not received any prior treatment. The study also explores a similar combination with a different drug, Obinutuzumab (ALO).

Patient Parameters

Parameter	Options

Program Overview

The study aims to evaluate the safety and effectiveness of two drug combinations for treating mantle cell lymphoma (MCL) in patients who have not been treated before. Participants will receive either Acalabrutinib, Lenalidomide, and Rituximab (ALR) or Acalabrutinib, Lenalidomide, and Obinutuzumab (ALO) for 12 cycles. If the treatment is working, they can continue with a maintenance phase until the disease progresses or they choose to stop. Participants will be monitored regularly to check for any remaining cancer cells and overall health.

Description

This study is designed to test the safety and effectiveness of two different drug combinations for treating mantle cell lymphoma (MCL) in patients who have not received any previous treatment. The two combinations being tested are Acalabrutinib, Lenalidomide, and Rituximab (ALR) and Acalabrutinib, Lenalidomide, and Obinutuzumab (ALO).

Participants will first go through an induction phase, receiving 12 cycles of either ALR or ALO. If the treatment is effective, they can move on to a maintenance phase, continuing the same treatment until the disease progresses, they experience unacceptable side effects, or they decide to withdraw from the study.

Participants will be monitored for minimal residual disease (MRD) in their blood at the start and after completing 12 cycles of treatment, and then every four cycles. After finishing the study treatment, participants will have follow-up visits every six months to monitor their health and any additional cancer treatments they may receive.

Eligibility Criteria

Inclusion Criteria

Diagnosed with mantle cell lymphoma.
Age 18 years or older.
No previous treatment for lymphoma.
Have a measurable tumor mass of at least 1.5 cm.
Treatment is recommended by the doctor.
Good overall health with an ECOG performance status of 0 to 2.
Meet specific blood and organ function requirements.
Able to take daily aspirin or an alternative blood thinner.
Agree to use birth control during the study and for 28 days after.
Women must have regular pregnancy tests and use two forms of birth control.
Men must use condoms and avoid donating sperm during the study.
Willing to sign an informed consent form and follow study procedures.

Exclusion Criteria

Have a specific aggressive form of MCL called blastoid histology.
Have cancer that has spread to the brain or spinal cord.
Have active infections like HIV or hepatitis B or C, unless controlled.
Have had another cancer in the past 5 years, except for certain skin or localized cancers.
Have uncontrolled infections or significant heart disease.
Have digestive issues that affect medication absorption.
Have bleeding disorders or uncontrolled autoimmune conditions.
Need certain medications that interfere with the study drugs.
Have had major surgery recently or have severe skin reactions.
Are pregnant or breastfeeding.
Have allergies to study drugs or are on certain medications.
Have used other experimental treatments recently.
Have medical conditions that would interfere with the study.

Locations

FACILITY	ZIP	CITY	STATE
Weill Cornell Medicine	10065	New York	New York

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