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Bruton's Tyrosine Kinase (BTK) Inhibitor

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

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
Estimated CrCL of ≥ 30 mL/min calculated by Cockcroft-Gault (using actual body weight) or serum creatinine < 2 × ULN
Must not have
Prior therapies such as corticosteroids, radio- or toxin-conjugated antibody therapy, allogeneic stem cell or autologous transplant
History of or ongoing confirmed progressive multifocal leukoencephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of randomization until pd (assessed up to 6.6 years)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compared two different treatment regimens for people with previously untreated CLL or SLL.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects include diarrhea, headache, fever, fatigue, muscle pain; low blood counts leading to increased infection risk; bleeding problems; allergic reactions; and potential liver dysfunction. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My physical ability hasn't worsened in the last 2 weeks.
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My kidney function is good enough for the trial.
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I am 18 years old or older.
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My CLL/SLL requires treatment as per 2018 guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had treatments like steroids, targeted antibody therapy, or stem cell transplants.
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I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.
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I need to take medication for stomach acid.
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My liver condition is classified as Child-Pugh B or C.
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I am on blood thinners like warfarin.
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I have a bleeding disorder or am currently experiencing active bleeding.
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I need medication that strongly affects liver enzyme levels.
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I haven't had major surgery in the last 28 days.
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I do not have uncontrolled autoimmune blood disorders.
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I have HIV or another serious infection.
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I haven't had serious heart issues in the last 6 months.
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I do not have any severe illness or organ problems that would prevent me from participating in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomization until pd (assessed up to 6.6 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization until pd (assessed up to 6.6 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Change from baseline in EORTC QLQ-CLL17 scales
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scales
Complete Response (CR) rate
+8 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
Headache
1%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2080
Obinutuzumab
2014
Completed Phase 3
~3470
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,390 Previous Clinical Trials
289,108,528 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05057494 — Phase 3
~335 spots leftby Jul 2027
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