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BTK Inhibitor

Acalabrutinib + Venetoclax + Durvalumab for Richter Syndrome

Phase 2
Recruiting
Led By Paul J. Hampel, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of CLL according to the IWCLL 2018 criteria or SLL according to the WHO 2008 criteria with specific documentation requirements
Biopsy-proven Richter's transformation of the CLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration to death due to any cause, assessed up to 5 years
Awards & highlights

Study Summary

This trial tests acalabrutinib, venetoclax, and durvalumab in treating Richter transformation, a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma.

Who is the study for?
Adults diagnosed with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma can join this trial. They must have a certain level of physical fitness, no pregnancy, and agree to use effective contraception. People who've had recent heart issues, uncontrolled infections, autoimmune diseases without remission for 3 years (except stable hypothyroidism), active pneumonitis, CNS involvement by cancer requiring therapy, or those on strong CYP3A inhibitors/inducers are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of acalabrutinib (blocks enzymes for cell growth), venetoclax (BCL-2 inhibitor stopping cancer cell survival), and durvalumab (monoclonal antibody boosting immune attack on cancer). It aims to see if this combo improves survival in patients with fast-growing types of lymphoma developed from other blood cancers.See study design
What are the potential side effects?
Potential side effects include diarrhea, risk of infection due to immune system suppression by durvalumab, liver function changes from acalabrutinib and venetoclax. There may also be risks related to low blood counts leading to fatigue or bleeding complications.

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 or SLL based on specific criteria.
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My CLL has transformed into a more aggressive form.
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My liver tests for bilirubin, AST, and ALT are within required ranges.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to death due to any cause, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
Incidence of adverse events
Overall response rate
Overall survival
+2 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
12%
Headache
2%
Respiratory failure
2%
Pneumonia
1%
Hypotension
1%
Acute kidney injury
1%
Pleural effusion
1%
Bacterial sepsis
1%
Mucosal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib, durvalumab, venetoclax)Experimental Treatment3 Interventions
Patients receive acalabrutinib PO BID on days 1-28, durvalumab IV over 1 hour on day 1, and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive acalabrutinib PO BID and venetoclax PO QD on days 1-90. Treatment repeats every 90 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2030
Durvalumab
2017
Completed Phase 2
~3870
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,478 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,308 Total Patients Enrolled
Paul J. Hampel, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Acalabrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05388006 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (acalabrutinib, durvalumab, venetoclax)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT05388006 — Phase 2
Acalabrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388006 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still recruiting participants?

"Yes, the data on clinicaltrials.gov suggests that this research endeavour is actively recruiting candidates. The study was first posted in 15th June 2022 and its most recent edit occurred on the same day. 33 individuals are required to be recruited from a single medical site."

Answered by AI

Could you please elucidate the risks associated with taking Acalabrutinib?

"While there has been some evidence of safety, Acalabrutinib's efficacy is still undemonstrated. As such, our team at Power graded its risk level as a 2 on the 1-3 scale."

Answered by AI

How many participants are partaking in this experiment at the most?

"Yes, indeed. The clinical trial is actively recruiting and the data hosted on clinicialtrials.gov suggests that recruitment began on June 15th 2022. 33 participants are needed at a single medical site for this study to be successful."

Answered by AI
~8 spots leftby Nov 2024