Acalabrutinib + Venetoclax for CLL

(MAVRiC Trial)

Not yet recruiting at 23 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
Must be taking: Covalent BTKi, BCL2i
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who've had a positive response to first-line BTKi + BCL2i therapy for at least two years. Participants should have an ECOG performance status of 0-2, indicating they are fully active or ambulatory and capable of all self-care but unable to carry out any work activities.

Inclusion Criteria

I am 18 years old or older.
I have been diagnosed with CLL/SLL following the 2018 guidelines.
I've had a successful first treatment with specific drugs for my condition over 2 years ago.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acalabrutinib Lead-in Treatment

Participants receive 2 cycles of acalabrutinib as lead-in treatment

8 weeks
2 visits (in-person)

AV Combination Treatment

Participants receive acalabrutinib plus venetoclax combination treatment

12-22 cycles (28 days each)
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-4 years
Every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acalabrutinib
  • Venetoclax

Trial Overview

The study tests the combination of Acalabrutinib and Venetoclax in patients with CLL/SLL who previously responded well to similar therapies. It aims to assess how effective and safe this drug duo is when given for a fixed period as a second treatment line.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Acalabrutinib and VenetoclaxExperimental Treatment2 Interventions

Find a Clinic Near You

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

AbbVie

Industry Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD