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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Chemotherapy for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Brad S Kahl, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible for autologous stem cell transplantation.
- Creatinine ≤ IULN OR creatinine clearance ≥ 40 mL/min for patients with creatinine levels above institutional normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights
Study Summary
This trial is designed to see if adding the drug acalabrutinib to a standard treatment regimen for mantle cell lymphoma is safe and improves outcomes.
Who is the study for?
This trial is for adults aged 18-70 with untreated mantle cell lymphoma who are eligible for stem cell transplantation. Participants must have adequate organ and bone marrow function, no history of significant bleeding disorders or major surgery within the last month, and not be on certain medications like strong CYP3A4 inhibitors or proton pump inhibitors. Pregnant or breastfeeding women cannot join.Check my eligibility
What is being tested?
The study tests acalabrutinib combined with bendamustine/rituximab followed by cytarabine/rituximab in patients with mantle cell lymphoma. The goal is to see if this regimen before a stem cell transplant can improve response rates and outcomes compared to current treatments.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the drugs used, bleeding complications, infections due to lowered immunity from chemotherapy, liver problems indicated by changes in blood tests, digestive issues that might affect drug absorption, and heart rhythm disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a stem cell transplant using my own cells.
Select...
My kidney function is within the normal range or slightly above.
Select...
My cancer can be measured on a PET scan.
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I can take care of myself but might not be able to do heavy physical work.
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I am between 18 and 70 years old.
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My lymphoma is confirmed to be mantle cell type with specific genetic markers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stem Cell Mobilization Success Rate With Cytarabine and Rituximab
Secondary outcome measures
Overall Response Rate (ORR = Complete Response (CR) + Partial Response (PR)) of Subjects
Overall Survival (OS)
Pre-transplant Complete Response Rate
+2 moreSide effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bendamustine/Rituximab/Acalabrutinib/CytarabineExperimental Treatment8 Interventions
Patients will receive (6) 28 day cycles
Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
After Cycle 6, patients will undergo leukapheresis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone marrow collection
2013
Completed Phase 1
~20
Oral rinse
2022
N/A
~20
Rituximab
1999
Completed Phase 4
~1880
Cytarabine
2016
Completed Phase 3
~3310
Peripheral blood
2018
Completed Phase 1
~70
Acalabrutinib
2020
Completed Phase 2
~2030
Bendamustine
2015
Completed Phase 3
~2950
Leukapheresis
2016
Completed Phase 2
~690
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,696 Total Patients Enrolled
Acerta Pharma BVIndustry Sponsor
45 Previous Clinical Trials
5,912 Total Patients Enrolled
Brad S Kahl, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a live virus vaccine in the last 28 days.I am allergic to certain medications used in this study.I need medication that strongly affects liver enzyme levels.My blood clotting tests are abnormal, but I'm not on warfarin.I am taking medication for stomach acid, like omeprazole.I am eligible for a stem cell transplant using my own cells.I do not have serious heart problems or recent heart attacks.I have a condition that affects how my body absorbs food.My kidney function is within the normal range or slightly above.I do not have active hepatitis B or C, or I have negative PCR results if previously exposed.I am HIV-positive and on antiretroviral therapy.My cancer can be measured on a PET scan.I can take care of myself but might not be able to do heavy physical work.I am taking warfarin or similar blood thinners.I have not had a stroke or brain bleed in the last 6 months.My blood tests for bone marrow and organ function are normal.My liver function tests are within acceptable limits, or any elevation is due to my lymphoma.I can understand and am willing to sign the consent form.I am between 18 and 70 years old.You are currently taking any other experimental drugs for medical research.I have been treated with a BTK inhibitor before.My lymphoma is confirmed to be mantle cell type with specific genetic markers.I have had chemotherapy or radiation for mantle cell lymphoma, but may have taken steroids for symptoms.I have symptoms from lymphoma in my brain.I have not had major surgery in the last 28 days or have fully recovered if I did.I do not have active bleeding or a history of bleeding disorders like hemophilia.I have uncontrolled AIHA or ITP.I do not have an ongoing infection that is not improving with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Bendamustine/Rituximab/Acalabrutinib/Cytarabine
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 research project still enrolling new participants?
"Unfortunately, this study is not enrolling new patients at the moment. The listing was first posted on November 29th, 2018 and last updated February 2nd, 2022. However, there are 1761 other trials recruiting lymphoma patients and 757 studies searching for participants that might be a good fit for Acalabrutinib."
Answered by AI
What other tests has Acalabrutinib been put through in the past?
"Acalabrutinib is being studied in 757 clinical trials, with 171 of those studies being Phase 3 trials. The majority of these Acalabrutinib trials are located in Wuhan, Other, however there are 27652 total locations for these active studies."
Answered by AI
What condition does Acalabrutinib help patients with the most?
"While commonly used to treat meningeal leukemia, Acalabrutinib has also been found to help patients with b-cell lymphomas, inflammatory breast cancer (IBC), and polyangiitis."
Answered by AI
How many participants are enrolling in this research project?
"This particular clinical study is no longer recruiting patients. However, there are 757 other active trials for Acalabrutinib and 1761 for lymphoma."
Answered by AI
What was the outcome of Acalabrutinib's FDA review process?
"Acalabrutinib's safety is supported by some data, but since this is only a Phase 2 trial, there is no evidence yet of the medication's efficacy. Therefore, our team rates its safety as a 2."
Answered by AI
Are octogenarians eligible for this research project?
"In order to take part in this trial, patients must fall between the ages of 18 and 70. There are 442 other studies available for patients that are underaged and 2236 trials for seniors."
Answered by AI
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