Acalabrutinib for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Leukemia, Lymphocytic, Chronic, B-Cell+4 More
Acalabrutinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.

Eligible Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Chronic, B-Cell

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 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

Year 3
Time to next treatment (TTNT)
Year 1
Discordant rate of uMRD between flow cytometry and NGS
Year 1
Progression-free survival
Year 3
Duration of response (DOR)
Up to 1 year
Incidence of adverse events
Numbers of T, B, and NK cells during and after therapy
Overall response rate (ORR)
Presence or absence of genomic features
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Leukemia, Lymphocytic, Chronic, B-Cell

Trial Design

2 Treatment Groups

Arm I (acalabrutinib, obinutuzumab)
1 of 2
Arm II (acalabrutinib, venetoclax)
1 of 2
Experimental Treatment

52 Total Participants · 2 Treatment Groups

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 2

Arm I (acalabrutinib, obinutuzumab)Experimental Group · 2 Interventions: Obinutuzumab, Acalabrutinib · Intervention Types: Biological, Drug
Arm II (acalabrutinib, venetoclax)Experimental Group · 2 Interventions: Acalabrutinib, Venetoclax · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2013
Completed Phase 3
~3200
Acalabrutinib
2020
Completed Phase 2
~1910
Venetoclax
2019
Completed Phase 3
~1670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
29 TrialsResearching Leukemia, Lymphocytic, Chronic, B-Cell
206 CompletedClinical Trials

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
281 Previous Clinical Trials
285,766 Total Patients Enrolled
6 Trials studying Leukemia, Lymphocytic, Chronic, B-Cell
156 Patients Enrolled for Leukemia, Lymphocytic, Chronic, B-Cell
Adam S Kittai, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years.
You have symptoms or signs of extranodal involvement.
You are 10% or more overweight.
You have a diagnosis of CLL/SLL meeting criteria established in the 2018 International Workshop (iw)CLL guidelines.
You have a node that is 10 centimeters or larger or you have symptoms of lymphadenopathy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.