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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + R-CHOP for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic diagnosis of MCL according to the World Health Organization classification
Men and women ≥ 18 years of age deemed eligible for treatment with full-dose R-CHOP and ASCT by the qualified investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study (up to 2 years)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining a new drug with standard chemotherapy, to see if it improves remission rates in patients with a certain type of lymphoma.
Who is the study for?
Adults with untreated mantle cell lymphoma eligible for R-CHOP chemotherapy and stem cell transplant can join this Canadian study. They must be able to swallow pills, understand the study risks, consent to it, and use effective birth control. Exclusions include central nervous system involvement, hypersensitivity to trial drugs, bleeding disorders, certain medication conflicts, recent major surgery or stroke, severe liver/kidney disease, other active cancers (with exceptions), significant heart issues, uncontrolled blood diseases like AIHA/ITP or live vaccinations recently.Check my eligibility
What is being tested?
This phase II trial tests acalabrutinib combined with R-CHOP chemo in patients before a stem cell transplant. Participants will take acalabrutinib twice daily with six cycles of R-CHOP and undergo scans and biopsies for response assessment. Successful responders proceed to stem cell collection followed by maintenance rituximab every three months for two years post-transplant.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever or fatigue; digestive disturbances; increased risk of infections; bleeding problems due to low platelet counts; liver enzyme changes indicating potential liver damage; muscle pains or cramps; headaches; and potentially serious cardiac arrhythmias.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is Mantle Cell Lymphoma (MCL) as per WHO standards.
Select...
I am 18 or older and eligible for R-CHOP and stem cell transplant treatment.
Select...
I have a tumor that can be measured on scans, larger than 1.5 cm if in a lymph node or 1.0 cm if elsewhere.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of study (up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study (up to 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma
Secondary outcome measures
Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0
Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Acalabrutinib with R-CHOP chemotherapyExperimental Treatment2 Interventions
Acalabrutinib 100mg twice per day orally with standard of care R-CHOP chemotherapy by IV every 21 days for a maximum of six cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,436 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had severe allergic reactions to the study drugs (acalabrutinib and specific components of R-CHOP), including the active ingredients or other substances in them.My diagnosis is Mantle Cell Lymphoma (MCL) as per WHO standards.My platelet count is below 50, but I can join if my low count is due to lymphoma in my bone marrow.I have a tumor that can be measured on scans, larger than 1.5 cm if in a lymph node or 1.0 cm if elsewhere.I have uncontrolled AIHA or ITP.I do not have a history of bleeding disorders like hemophilia.I have trouble swallowing pills or have a condition that affects how my body absorbs medication.I am taking or need to take medication for stomach acid, like omeprazole.I do not have HIV or any serious infections.I have not had major surgery in the last 4 weeks or have fully recovered if I did.I have MCL and may have had limited prior treatments but no full treatment courses.I am 18 or older and eligible for R-CHOP and stem cell transplant treatment.I am using or willing to use effective birth control during and after treatment.I do not have active hepatitis B or C according to recent tests.I do not have serious heart problems or recent heart attacks.I am taking warfarin or similar blood thinners.I have not had a live virus vaccine in the last 28 days.My white blood cell count is low, but I may still qualify if my lymphoma affects my bone marrow.I can take care of myself and am up and about more than half of my waking hours.I need treatment with a strong medication that affects liver enzymes.I have not had a stroke or brain bleed in the last 6 months.My cancer has spread to my brain.I have no active cancer except for certain skin cancers, in situ cervical cancer, or any cancer I've been free from for 2+ years.I have been treated with specific inhibitors for my condition before.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib with R-CHOP chemotherapy
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.
What preceding investigations have been conducted with R-CHOP chemotherapy?
"Initially researched at the National Institutes of Health Clinical Center, R-CHOP chemotherapy has grown to encompass 2442 completed trials. Currently 1482 active studies are recruiting participants, many located in Halifax, Nova Scotia."
Answered by AI
What condition is R-CHOP chemotherapy most frequently prescribed for?
"R-CHOP chemotherapy is a common treatment for lung cancers and it has been known to treat other health concerns such as small cell lung cancer (SCLC), thyroiditis, and polyangium."
Answered by AI
How many participants have enrolled in this clinical experiment thus far?
"This trial necessitates 54 eligible patients to complete the course of treatment. People can partake in this clinical study from diverse locations, including QEII Health Sciences Centre in Halifax and Centre Hospitalier Universitaire de Québec in Quebec City."
Answered by AI
Are there any opportunities for participation in this research trial presently available?
"Affirmative. According to information hosted on clinicaltrials.gov, this scientific research is currently seeking participants for enrollment. It was initially posted online on March 1st 2021 and updated lastly on the 17th of March 2022. 54 volunteers need to be recruited from 4 distinct sites."
Answered by AI
Has the FDA sanctioned R-CHOP chemotherapy for use?
"With Phase 2 data indicating the safety of R-CHOP chemotherapy, our team at Power assigned a score of two to this particular treatment. While there is evidence for its security, no research has been conducted yet that affirms its efficacy."
Answered by AI
What is the scope of this medical trial in terms of participating healthcare centers?
"This medical trial is currently recruiting individuals from 4 different sites, which include Halifax, Quebec City and Toronto as well as other unspecified cities. To reduce travel expenses for participants, it may be most beneficial to choose the closest site to you when enrolling in this study."
Answered by AI
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