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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

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 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
2%
Headache
1%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,880 Total Patients Enrolled
1,399 Trials studying Lymphoma
382,743 Patients Enrolled for Lymphoma
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,325 Total Patients Enrolled
64 Trials studying Lymphoma
27,681 Patients Enrolled for Lymphoma
Sameer A ParikhPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
1 Trials studying Lymphoma

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03516617 — Phase 2
Lymphoma Research Study Groups: Arm A (acalabrutinib), Arm B (acalabrutinib, obinutuzumab), Arm C (observation)
Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT03516617 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03516617 — Phase 2
~8 spots leftby Mar 2025
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