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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib +/- Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Sameer A Parikh

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

Diagnosis of biopsy-proven small lymphocytic lymphoma (SLL)

Must not have

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is studying how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who is the study for?

Adults diagnosed with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma, who have not been treated before, can join this trial. They must be in good health overall and able to provide blood and saliva samples for research. Pregnant or nursing individuals, those with certain heart conditions, active infections like hepatitis B/C or HIV on treatment are excluded.

What is being tested?

The trial is testing the effectiveness of acalabrutinib alone versus combined with obinutuzumab in treating patients. Acalabrutinib blocks enzymes that cancer cells need to grow while obinutuzumab may help the immune system attack cancer.

What are the potential side effects?

Acalabrutinib might cause headaches, diarrhea, muscle pain, and increased risk of bleeding. Obinutuzumab can lead to infusion reactions (like fever), low blood cell counts increasing infection risk, and potential liver problems.

Eligibility Criteria

Inclusion Criteria

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

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

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I have been diagnosed with small lymphocytic lymphoma.

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I have not received any treatment for my condition.

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My tests show I do not have mantle cell lymphoma.

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I have been diagnosed with chronic lymphocytic leukemia.

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I am 18 years old or older.

Exclusion Criteria

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

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I am not on any experimental drugs for my cancer.

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I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.

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I have previously been treated with specific cancer drugs like ibrutinib or venetoclax.

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I am recommended to undergo chemotherapy.

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I am HIV positive and currently on antiretroviral therapy.

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

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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 have a bleeding disorder like hemophilia.

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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I have been diagnosed with lymphoma or leukemia in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Rate of minimal residual disease (MRD)-negative complete response (Arm A and Arm B)

Time to first therapy in patients (Arm C)

Secondary study objectives

Incidence of adverse events rates (Arms A and B)

Overall response rate (Arms A and B)

Overall survival (Arm C)

+4 more

Other study objectives

Bone marrow hematopoiesis (Arms A and B)

Percent killing of chronic lymphocytic leukemia (CLL) B-cells (Arms A and B)

Quality of life measures

+2 more

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

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (acalabrutinib, obinutuzumab)Experimental Treatment4 Interventions

Patients receive acalabrutinib PO BID on days 1-28 and obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1 and days 1 of subsequent cycles. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive acalabrutinib PO BID on days 1-84. Treatment repeats every 84 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment with acalabrutinib If MRD negative CR/CRi is not achieved after 12 cycles.

Group II: Arm A (acalabrutinib)Experimental Treatment3 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive acalabrutinib PO BID on days 1-84. Treatment repeats every 84 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment with acalabrutinib If MRD negative CR/CRi is not achieved after 12 cycles.

Group III: Arm C (observation)Active Control3 Interventions

Patients will be observed every 6 months for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

FDA approved

Obinutuzumab

FDA approved

0 / 16Eligibility criteria met