What side effects are associated with this type of intervention?

Common treatments for Mantle Cell Lymphoma (MCL) include BTK inhibitors like Acalabrutinib and Ibrutinib, often used in combination with other agents such as Venetoclax and Rituximab. Acalabrutinib and Ibrutinib are associated with side effects like increased risk of bleeding, atrial fibrillation, hypertension, and infections. Venetoclax can cause tumor lysis syndrome, neutropenia, and gastrointestinal issues. Rituximab may lead to infusion reactions, infections, and cytopenias. These treatments require careful monitoring and dose adjustments based on patient tolerance and comorbidities.

What prior FDA approvals exist?

The FDA has approved several treatments for Mantle Cell Lymphoma (MCL), including BTK inhibitors like Ibrutinib and Acalabrutinib. Ibrutinib was one of the first BTK inhibitors approved for MCL and has shown significant efficacy in both relapsed and refractory cases. Acalabrutinib, another BTK inhibitor, offers a similar mechanism of action with a different toxicity profile, providing an alternative for patients who may not tolerate Ibrutinib well. Other treatments for MCL include the proteasome inhibitor Bortezomib and the monoclonal antibody Rituximab, often used in combination with chemotherapy agents.

What other types of research exist?

Promising novel alternatives to Acalabrutinib for Mantle Cell Lymphoma patients include Venetoclax, which has shown efficacy in combination with other agents like Rituximab, and ONO/GS-4059, another selective BTK inhibitor that has demonstrated high response rates in relapsed/refractory B-cell malignancies. Additionally, combinations such as Bendamustine plus Rituximab or newer regimens involving immunotherapeutic approaches may also be considered.

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Kinase Inhibitor

Acalabrutinib + Venetoclax + Rituximab for Mantle Cell Lymphoma (TrAVeRse Trial)

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 67 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include diarrhea; headache; fever; fatigue; muscle pain; bruising; nausea; constipation; vomiting; rash as well as more serious ones such as bleeding problems, high blood pressure, irregular heartbeat among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 67 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 67 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 67 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MRD-negative CR rate

Secondary study objectives

Complete Response (CR) rate

Duration of Response (DoR)

Event Free Survival (EFS)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acalabrutinib + Venetoclax + RituximabExperimental Treatment3 Interventions

Acalabrutinib + Venetoclax + Rituximab (AVR)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Venetoclax

2019

Completed Phase 3

~2240

Acalabrutinib

2020

Completed Phase 2

~2080

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mantle Cell Lymphoma (MCL) treatments often target specific pathways crucial for cancer cell survival and proliferation. Acalabrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, blocks BTK, a protein essential for B-cell receptor signaling, thereby inhibiting the growth and survival of malignant B-cells. Venetoclax targets B-cell lymphoma 2 (BCL-2) proteins, promoting cancer cell apoptosis. Rituximab is a monoclonal antibody that binds to the CD20 antigen on B-cells, marking them for destruction by the immune system. These targeted therapies are significant for MCL patients as they offer more precise and effective treatment options with potentially fewer side effects compared to traditional chemotherapy.