Acalabrutinib for Richter's Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MN
Richter's Syndrome+6 More
Acalabrutinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests whether acalabrutinib, venetoclax, and durvalumab work in treating patients with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma. Richter transformation is a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib, venetoclax, and durvalumab may help improve survival in patients with Richter transformation.

Eligible Conditions

  • Richter's Syndrome
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Richter's Syndrome

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From registration to death due to any cause, assessed up to 5 years

Month 6
Progression free survival
Year 5
Overall survival
Year 2
Progression-free survival (PFS)
Year 5
Treatment-free survival
Up to 1 year
Overall response rate
Day 30
Incidence of adverse events

Trial Safety

Safety Progress

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

Other trials for Richter's Syndrome

Trial Design

1 Treatment Group

Treatment (acalabrutinib, durvalumab, venetoclax)
1 of 1
Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 2

Treatment (acalabrutinib, durvalumab, venetoclax)Experimental Group · 3 Interventions: Acalabrutinib, Durvalumab, Venetoclax · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~1910
Durvalumab
2017
Completed Phase 2
~3200
Venetoclax
2019
Completed Phase 3
~1670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from registration to death due to any cause, assessed up to 5 years
Closest Location: Mayo Clinic in Rochester · Rochester, MN
Photo of Rochester 1Photo of Rochester 2Photo of Rochester 3
2021First Recorded Clinical Trial
3 TrialsResearching Richter's Syndrome
507 CompletedClinical Trials

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,686,128 Total Patients Enrolled
2 Trials studying Richter's Syndrome
83 Patients Enrolled for Richter's Syndrome
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,427 Total Patients Enrolled
10 Trials studying Richter's Syndrome
323 Patients Enrolled for Richter's Syndrome
Wei DingPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Richter's Syndrome
65 Patients Enrolled for Richter's Syndrome

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be willing to give informed consent and follow-up for 12 months.
You have clonal immunoglobulin heavy chain variable [IGHV] gene rearrangement.
You have lymphadenopathy, splenomegaly, or hepatomegaly.
You have a peripheral blood B cell count less than 5 x 10^9/L.
You have CLL and you are not eligible for standard therapy.

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.