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BTK Inhibitor
AVD Therapy for Richter Transformation
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
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
Timeline
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 belowSelect...
Swollen spleen, liver, or lymph nodes are not needed to confirm you have chronic lymphocytic leukemia (CLL).
Select...
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.
Select...
Your lymphocytes have specific markers called CD19, CD20, CD23, and CD5, but do not have other markers like CD3 or CD2.
Select...
You have been diagnosed with a type of cancer called Richter's transformation of the CLL, which has been confirmed by a biopsy.
Select...
Your cells show specific markers indicating that they come from the same clone or family of cells.
Select...
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.
Select...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to death due to any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to death due to any cause, assessed up to 5 years
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 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT0434619912%
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2030
Durvalumab
2017
Completed Phase 2
~3030
Venetoclax
2019
Completed Phase 3
~2100
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You are 18 years old or older and willing to agree to participate in the study and come back for check-ups.You have had surgery to prevent pregnancy by blocking or cutting your fallopian tubes.You have been diagnosed with a type of cancer called Richter's transformation of the CLL, which has been confirmed by a biopsy.You have heart failure.If you are taking a type of birth control pill called "minipill" that contains desogestrel (brand name Cerazette), you cannot participate.You are currently breastfeeding.You have either vitiligo or alopecia.You have had a previous cancer diagnosis, except for:You have a type of cancer that grows slowly and you are expected to live for more than 2 years.You cannot use nasal sprays, inhalers, skin creams, or steroid injections.Your doctor believes you have less than 3 months to live.Swollen spleen, liver, or lymph nodes are not needed to confirm you have chronic lymphocytic leukemia (CLL).You do not need to have an enlarged spleen, liver, or lymph nodes to be diagnosed with CLL.You are pregnant.You currently have chronic GVHD that needs to be treated.The following methods are considered effective:You are using a Copper T intrauterine device (IUD) for birth control.You are using a specific type of intrauterine device (IUD) that releases levonorgestrel (e.g., Mirena).You have an etonogestrel-releasing implant such as Implanon or Norplant.You have received a birth control injection called Depo-Provera or medroxyprogesterone.You have a sickness that is not under control.You have a heart condition that could be dangerous to your health.You have severe heart disease categorized as class 3 or 4 by the New York Heart Association.Your high blood pressure is not under control.You have inconsistent or unpredictable chest pain caused by heart disease.You can join the study even if you have atrial fibrillation, as long as it is under control and you aren't experiencing any symptoms.You have had a stroke or bleeding in your brain in the last 6 months before starting the study.You cannot participate if you are pregnant or planning to become pregnant because the safety of the study drug on developing fetuses and newborns is unknown.You have recently received an experimental medication (excluding venetoclax, acalabrutinib, or ibrutinib) and it has not yet cleared your system. You should talk to the study chair to find out if this exclusion applies to the specific medication you took.You have already received durvalumab treatment before. However, if you have received other similar treatments called PD1 or PDL1 blockade, you may still be eligible.You have a long-term skin condition that does not need medication taken throughout your whole body.You have a mental health or drug abuse condition that could make it difficult for you to follow the trial requirements.You have received steroids as a premedication for hypersensitivity reactions, such as before a CT scan.Your lymphocytes have specific markers called CD19, CD20, CD23, and CD5, but do not have other markers like CD3 or CD2.You have a type of cancer called Richter's Syndrome and your doctor has determined that you do not have any other options for standard treatment. You also have a diagnosis of Chronic Lymphocytic Leukemia (CLL).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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib, durvalumab, venetoclax)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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