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Protein Inhibitor

Acalabrutinib + Venetoclax/Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Kerry S Rogers, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop (iw)CLL guidelines

Be older than 18 years old

Must not have

Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura

Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the first tumor assessment supports the response, at 1 and 3 years, or to the time of confirmed disease progression or death due to any cause

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether a combination of drugs shrinks tumors in patients with treatment-naive chronic lymphocytic leukemia.

Who is the study for?

Adults diagnosed with chronic lymphocytic leukemia who haven't had previous cancer treatments, except for certain conditions like autoimmune diseases or symptom control. They must show specific symptoms or blood abnormalities as per iwCLL guidelines, have adequate organ function, and women of childbearing age must use effective contraception.

What is being tested?

The trial is testing acalabrutinib combined with either venetoclax or obinutuzumab to see if they can shrink tumors in patients with untreated chronic lymphocytic leukemia. Patients will first receive acalabrutinib alone, then be randomly assigned to add one of the other drugs for further treatment cycles.

What are the potential side effects?

Possible side effects include diarrhea, headache, increased risk of bleeding and infection due to low blood cell counts, irregular heart rhythm, muscle pain, and fatigue. Some may experience allergic reactions to the monoclonal antibody obinutuzumab.

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 according to the 2018 guidelines.

Exclusion Criteria

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

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I have uncontrolled autoimmune blood disorders.

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I am on blood thinners like warfarin.

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I cannot swallow pills or have serious stomach/intestine problems.

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I take more than 20 mg of prednisone daily for an autoimmune disease.

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I have a serious heart condition.

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I am not taking any drugs that strongly affect liver enzymes.

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My lymphoma or leukemia has spread to my brain or spinal cord.

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I do not have any other cancers that could shorten my life to under 2 years.

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I have been diagnosed with HIV.

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I am currently on IV antibiotics or antivirals for an infection.

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I have a bleeding disorder or am currently experiencing active bleeding.

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I need medication for stomach acid.

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I have not had major surgery within the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 3 years up to time from start of combination therapy until next treatment is initiated

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 3 years up to time from start of combination therapy until next treatment is initiated

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 3 years up to time from start of combination therapy until next treatment is initiated for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of bone marrow undetectable minimal residual disease (uMRD), defined as tumor cell in 10,000 cells using standard flow based assay, achieved after completion of therapy

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events

Overall response rate (ORR)

+2 more

Other study objectives

Discordant rate of uMRD between flow cytometry and NGS

Numbers of T, B, and NK cells during and after therapy

Presence or absence of genomic features

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

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

2Treatment groups

Experimental Treatment

Group I: Arm II (acalabrutinib, venetoclax)Experimental Treatment2 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Patients also receive venetoclax PO QD on days 1-28 days of cycles 13-18. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (acalabrutinib, obinutuzumab)Experimental Treatment2 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 13 and day 1 of cycles 14-18. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tyrosine

FDA approved

Obinutuzumab

FDA approved

Venetoclax

FDA approved

0 / 14Eligibility criteria met