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Kinase Inhibitor

Acalabrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Meghan Thompson, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

≥ 18 years-old

A woman is considered of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)

Must not have

Active bleeding, or presence of known bleeding disorder (e.g. von Willebrand's disease) or hemophilia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether it is safe to stop treatment with acalabrutinib and obinutuzumab after the cancer responds to the treatment, followed by a period of observation.

Who is the study for?

This trial is for adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment. Participants must be able to follow the study plan, have normal organ function, and if of childbearing potential, agree to use effective contraception. People can't join if they've had prior CLL therapy, bleeding disorders, severe heart conditions, recent major surgery or infections requiring hospitalization within 2 weeks before starting the study.

What is being tested?

The trial tests whether stopping acalabrutinib and obinutuzumab when cancer responds—followed by a watchful waiting period—is as effective as continuous treatment until disease progression. This approach aims to reduce long-term side effects and prevent resistance to treatment.

What are the potential side effects?

Potential side effects include diarrhea, headache, high blood pressure from acalabrutinib; infusion reactions like fever or chills and low blood cell counts from obinutuzumab. Long-term use may lead to serious complications such as increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am a woman who can still have children.

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I have untreated CLL or SLL and need treatment according to 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 active bleeding or a bleeding disorder like von Willebrand's disease or hemophilia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Adverse events from Acalabrutinib with Obinutuzumab

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: Acalabrutinib Combined With ObinutuzumabExperimental Treatment2 Interventions

Patients will receive acalabrutinib for a minimum of 13 cycles and maximum 26 cycles and Obinutuzumab will be administered during Cycles 2-7. This will be followed by treatment-free observation through the 65th cycle. Patients who progress during the observation period, per iwCLL criteria, will receive 13 cycles of acalabrutinib in combination with obinutuzumab in the retreatment phase of this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

2014

Completed Phase 3

~3470

Acalabrutinib

2020

Completed Phase 2

~2110