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Bruton's Tyrosine Kinase (BTK) Inhibitor

Venetoclax + Obinutuzumab +/- Acalabrutinib for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Jacob D Soumerai, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Age over 18 years

Diagnosis of CLL or SLL according to WHO criteria

Must not have

Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)

Known CNS hemorrhage or stroke within 6 months of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if they are effective in treating CLL or SLL. The drugs involved are obinutuzumab, venetoclax, and acalabrutinib.

Who is the study for?

Adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment and have previously received systemic therapy. They must be in good enough health, not pregnant, agree to contraception, and not have certain heart conditions or other serious illnesses that could interfere with the study.

What is being tested?

The trial is testing a combination of drugs: obinutuzumab, venetoclax, and possibly acalabrutinib. It aims to find out if these drugs can effectively treat CLL/SLL when given together compared to current standard treatments.

What are the potential side effects?

Possible side effects include infections due to a weakened immune system, allergic reactions to the medication components, liver problems, digestive issues like nausea or diarrhea, fatigue, and an increased risk of bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I have been diagnosed with CLL or SLL.

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My kidney function, measured by creatinine or its clearance, is within the normal range.

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I have received treatment for chronic lymphocytic leukemia.

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I can care for myself but may not be able to do active work.

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My CLL is classified as high or intermediate risk.

Exclusion Criteria

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

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My CLL has transformed into an aggressive form of lymphoma.

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I have not had a brain hemorrhage or stroke in the last 6 months.

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I need medication to prevent blood clots.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.

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I have had progressive multifocal leukoencephalopathy in the past.

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I haven't taken strong medication affecting liver enzymes in the last week.

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I have a history of HIV or active hepatitis B or C.

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I have a significant history of liver problems.

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I haven't had major surgery in the last 4 weeks and don't expect to need one soon.

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I tested positive for hepatitis C but do not currently have the virus in my blood.

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I have severe heart failure.

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I have a condition that affects how my body absorbs medication taken by mouth.

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I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

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

Percentage of participants alive at 1 year

Secondary study objectives

Complete response rate

Frequency of undetectable minimum residual disease (uMRD) after 12 Months

Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE ver. 5.0.

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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: Venetoclax-Obinutuzumab +/- AcalabrutinibExperimental Treatment3 Interventions

A treatment cycle is defined as 28 consecutive days. Participants with undetectable MRD (uMRD) at 1 year will complete an additional 1 year of VO then stop therapy. Participants with high detectable MRD at 1 year will complete an additional 1 year of VO plus acalabrutinib then stop therapy. Participants with low detectable MRD at 1 year will complete an additional 1 year of VO alone. If this eradicates MRD, they will stop therapy. If there is still residual MRD, they will complete an additional 1 year of IVO then stop therapy. If progression occurs on VO, I will be added and IV will be administered indefinitely. After 2 years, V may be stopped and I continued as monotherapy at investigator discretion. * Infused Study Drug: Obinutuzumab on Days 1, 2, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 1-6 * Oral Study Drugs: Venetoclax daily starting on Cycle 1 Day 22 * Oral Drug: acalabrutinib daily for Days 1-28 (if applicable)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

FDA approved

Obinutuzumab

FDA approved

Acalabrutinib

FDA approved

0 / 20Eligibility criteria met