Acalabrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Lymphoma
(MAJIC Trial)

Recruiting in Palo Alto (17 mi)

+40 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Eligibility Criteria

This trial is for adults with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment. Participants must have good bone marrow and liver function, a certain level of kidney function, and be in stable health. They can't join if they've had previous CLL/SLL treatments (except some rituximab), stem cell transplants, significant heart issues within the last 6 months, active infections like HIV or hepatitis B/C, or other conditions that could affect safety.

Inclusion Criteria

Meet specific laboratory parameters

I can swallow pills without any trouble and can follow the study's procedures.

My physical ability hasn't worsened in the last 2 weeks.

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Exclusion Criteria

Concurrent participation in another therapeutic clinical trial

Serologic status reflecting active hepatitis B or C infection

Known history of hypersensitivity or anaphylaxis to study intervention(s)

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Treatment Details

Interventions

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Obinutuzumab (Monoclonal Antibodies)
Venetoclax (B-cell Lymphoma-2 (BCL-2) Inhibitor)

Trial OverviewThe study compares two drug combinations: Acalabrutinib plus Venetoclax (AV) versus Venetoclax plus Obinutuzumab (VO). It aims to determine which combination works better for patients who haven't been treated before for their blood cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm B: Venetoclax plus Obinutuzumab (VO)Experimental Treatment2 Interventions

Participants will receive Venetoclax orally and Obinutuzumab via IV infusion.

Group II: Arm A: Acalabrutinib plus Venetoclax (AV)Experimental Treatment2 Interventions

Participants will receive acalabrutinib and venetoclax orally.

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

🇺🇸 Approved in United States as Calquence for: