Acalabrutinib + Lenalidomide + Rituximab for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByJia Ruan, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new treatment for patients with untreated mantle cell lymphoma. The treatment aims to stop cancer growth, help the immune system fight the cancer, and directly target and kill the cancer cells.

Eligibility Criteria

This trial is for adults with untreated mantle cell lymphoma who need treatment, have good liver and kidney function, can follow the study schedule, and agree to use birth control. People with certain heart conditions, active infections like HIV or hepatitis B/C, recent major surgery, other cancers within 5 years (except some skin or localized cancers), or those on specific medications are excluded.

Inclusion Criteria

I am registered and can follow the Revlimid REMS program.

I can take care of myself and do some daily activities.

I have not had any drug treatments for lymphoma.

I am 18 years old or older.

My tumor is larger than 1.5 cm or my spleen is affected.

My diagnosis is mantle cell lymphoma confirmed by tissue analysis.

Exclusion Criteria

I have a condition that affects how my body absorbs food.

I am at high risk for blood clots and refuse to take preventive medication.

I do not have a bleeding disorder like hemophilia.

My cancer has blastoid features.

I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

I have not had major surgery in the last 28 days or have fully recovered from it.

My cancer has spread to my brain.

I have been treated with a BTK inhibitor before.

I do not have an ongoing serious infection that isn't getting better with treatment.

I have uncontrolled AIHA or ITP.

Participant Groups

The trial tests a combination of acalabrutinib, lenalidomide and rituximab (ALR) in patients with untreated mantle cell lymphoma over an induction phase of 12 cycles followed by maintenance therapy until disease progression or unacceptable side effects occur. The effectiveness and safety of this regimen will be monitored throughout the study.

1Treatment groups

Experimental Treatment

Group I: ALR in CombinationExperimental Treatment3 Interventions

Acalabrutinib, lenalidomide, and rituximab in combination

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: