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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Jan A Burger

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Diagnosis CLL/small lymphocytic lymphoma (SLL) and be untreated

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)

Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after completion of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether a combination of two drugs, acalabrutinib and obinutuzumab, can effectively treat patients with chronic lymphocytic leukemia.

Who is the study for?

This trial is for patients with chronic lymphocytic leukemia (CLL) who haven't been treated before. They should have a creatinine clearance over 30 mL/min, normal liver function tests, and no prior malignancies within the last 2 years except certain skin cancers or 'in situ' carcinomas. Participants must be willing to use effective birth control and not be pregnant or breastfeeding. People with previous CLL treatments, significant infections, uncontrolled heart conditions, recent strokes or surgeries are excluded.

What is being tested?

The trial is testing how well acalabrutinib combined with obinutuzumab works in treating CLL. Acalabrutinib blocks enzymes needed for tumor growth while obinutuzumab may help the immune system interfere with tumor cell growth and spread. The goal is to see if this combination can better manage disease progression in untreated CLL patients.

What are the potential side effects?

Potential side effects include allergic reactions to medication components, issues swallowing pills due to gastrointestinal diseases that limit absorption of oral meds, bleeding disorders within the past three months, non-healing wounds or fractures, and complications from strong CYP3A4 inhibitors/inducers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CLL/SLL and have not received any treatment.

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I am able to care for myself and perform daily activities.

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My condition requires treatment according to the 2018 IWCLL guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled autoimmune blood disorders.

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I can't swallow pills or have a stomach condition affecting medication absorption.

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I have not had major surgery or a serious injury in the last 28 days.

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I need treatment with a strong medication that affects liver enzymes.

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I have a serious wound or fracture that is not healing.

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I need medication for stomach acid.

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I do not have HIV or any uncontrolled infections.

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I have been treated for CLL/SLL before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months after discontinuation of acalabrutinib, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months after discontinuation of acalabrutinib, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after discontinuation of acalabrutinib, up to 4 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

Overall response rate

Treatment-free remission

Secondary study objectives

Therapeutic procedure

Success rate of re-treatment in patients who relapse

Treatment-free remission length

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (acalabrutinib, obinutuzumab)Experimental Treatment2 Interventions

Patients receive acalabrutinib PO BID every 12 hours starting on day 1 of cycle 1, and obinutuzumab IV over 4-6 hours on days 1 and 2 of cycle 3, and day 1 of cycles 4-8. Patients who do not achieve a complete response or remission after cycle 8 may receive single-agent acalabrutinib therapy PO BID for an additional 6 cycles at the discretion of their treating physician. Patients who are in partial response or who have stable disease receive an additional 6 cycles of acalabrutinib PO BID and obinutuzumab IV. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

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