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BTK Inhibitor

AVD Therapy for Richter Transformation

Phase 2
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
NOTE: Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
Biopsy-proven SLL according to WHO 2008 criteria, or Peripheral blood B cell count of >= 5 x 10^9/L consisting of small to moderate size lymphocytes (If there are enough evidence to document the prior diagnosis of CLL, it is not required to meet the criteria of peripheral blood B cell count more than 5 x 10^9/L )
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upfrom registration to death due to any cause, assessed up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Richter Syndrome
  • Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Swollen spleen, liver, or lymph nodes are not needed to confirm you have chronic lymphocytic leukemia (CLL).
You have been diagnosed with a type of lymphoma called SLL, or you have a high level of small to moderate lymphocytes in your blood. If you have already been diagnosed with CLL, you don't need to have a high level of lymphocytes in your blood.
Your lymphocytes have specific markers called CD19, CD20, CD23, and CD5, but do not have other markers like CD3 or CD2.
You have been diagnosed with a type of cancer called Richter's transformation of the CLL, which has been confirmed by a biopsy.
Your cells show specific markers indicating that they come from the same clone or family of cells.
Before being diagnosed with CLL or SLL, the doctors have to make sure that you don't have mantle cell lymphoma. They will do this by checking your blood or tissue samples to see if there is a specific genetic marker (t(11;14)(IgH/CCND1)) or protein (cyclin D1) present.
If you were diagnosed with chronic lymphocytic leukemia (CLL) and had a bone marrow or tissue biopsy, you can still participate if your B cell count is above 5 x 10^9/L.
You can participate in the trial even if you have received treatment for your CLL in the past. However, if your CLL transformed into Richter's syndrome and you have not received any treatment for it, you cannot participate.


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
Respiratory failure
Acute kidney injury
Pleural effusion
Bacterial sepsis
Mucosal infection
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2
Completed Phase 2
Completed Phase 3

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,119 Previous Clinical Trials
3,510,703 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,492 Previous Clinical Trials
41,267,548 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
~13 spots leftby Nov 2024