Acalabrutinib + Venetoclax + Rituximab for Mantle Cell Lymphoma

(TrAVeRse Trial)

Recruiting at 41 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial uses a combination of three drugs to treat patients with a specific type of lymphoma who haven't been treated before. The goal is to see if this combination can effectively eliminate cancer cells and if patients can stop treatment without the cancer coming back. The treatment works by blocking growth signals, killing cancer cells, and boosting the immune system. Rituximab, combined with chemotherapy, has been shown to be highly effective in treating indolent lymphomas.

Eligibility Criteria

This trial is for adults with newly diagnosed Mantle Cell Lymphoma (MCL) who need treatment and have not received any prior therapies for MCL. They should be in clinical Stage II, III, or IV, able to consent, and have at least one measurable site of disease. Participants must agree to use effective contraception and cannot join if they are pregnant or breastfeeding, have severe illnesses that could affect the study's safety or outcomes, active infections like HIV/Hepatitis B/C, other active cancers (with some exceptions), significant heart issues, or known allergies to the drugs being tested.

Inclusion Criteria

My condition is at a moderate to advanced stage and needs treatment.

My tumor samples are available for detailed genetic testing.

My cancer is confirmed as mantle cell lymphoma with specific genetic features.

Exclusion Criteria

I do not have uncontrolled autoimmune blood disorders.

Participants with a known hypersensitivity to acalabrutinib, venetoclax, or rituximab or any of the excipients of the product

Currently pregnant or breast feeding

Treatment Details

Interventions

• Acalabrutinib (Kinase Inhibitor)
• Rituximab (Monoclonal Antibody)
• Venetoclax (BCL-2 Inhibitor)

Trial Overview The TrAVeRse study tests a combination of Acalabrutinib plus Venetoclax and Rituximab (AVR) in treatment-naïve MCL patients. It aims to see how many achieve MRD-negative complete remission after 13 cycles of AVR. Those who do will either continue with Acalabrutinib or enter observation. If participants progress during observation, they may receive Acalabrutinib again.

Participant Groups

Group I: Acalabrutinib + Venetoclax + Rituximab Experimental Treatment 3 Interventions

Acalabrutinib + Venetoclax + Rituximab (AVR)

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology