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Protein Kinase Inhibitor
Combination Chemotherapy + Acalabrutinib for Mantle Cell Lymphoma
Phase 2
Recruiting
Led By Stephen D Smith
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
Documented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of registration to the date of progression (or relapse),or death due to any cause, whichever comes first, assessed at 2 years post-registration
Awards & highlights
Study Summary
This trial is testing how well a combination of drugs works as first line treatment for mantle cell lymphoma. The drugs work in different ways to stop the growth of cancer cells.
Who is the study for?
This trial is for transplant-eligible patients aged 18-75 with mantle cell lymphoma who haven't had prior systemic treatment. They must have measurable disease, acceptable organ function, and an ECOG performance status of 0-2. Women of childbearing potential and men must agree to effective contraception during the study and afterwards.Check my eligibility
What is being tested?
The trial investigates a modified VR-CAP (a combination of chemotherapy drugs) plus acalabrutinib as first-line therapy compared to standard treatments. It aims to see if this new combo is more effective in treating mantle cell lymphoma before a patient undergoes a stem cell transplant.See study design
What are the potential side effects?
Potential side effects include reactions from monoclonal antibodies like Rituximab, chemo-related nausea, hair loss, fatigue, increased risk of infection due to low blood counts, liver toxicity indicated by elevated bilirubin or AST levels, and possible bleeding complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but may not be able to do heavy physical work.
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My scans show at least one cancer spot larger than 1.5 cm or an enlarged spleen.
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I am between 18 and 75 years old.
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I have not received any treatment for mantle cell lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to death due to any cause, assessed at 2 years post-registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to death due to any cause, assessed at 2 years post-registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of complete responses to therapy (complete metabolic response [CMR])
Secondary outcome measures
Feasibility of stem cell collection
Incidence of adverse events
MRD rate
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (modified VR-CAP, acalabrutinib)Experimental Treatment8 Interventions
CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5.
CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2.
Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Acalabrutinib
2020
Completed Phase 2
~2050
Bortezomib
2005
Completed Phase 2
~1140
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,091 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,860 Total Patients Enrolled
Stephen D SmithPrincipal InvestigatorAcademic and Community Cancer Research United
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Mantle Cell Lymphoma requires treatment, and I might be a candidate for a stem cell transplant.I do not have an active infection that is getting worse or needs IV antibiotics.I have uncontrolled AIHA or ITP.I cannot swallow pills or have a stomach condition that affects medication absorption.I need treatment with a strong medication that affects liver enzymes.I can take care of myself but may not be able to do heavy physical work.I do not have any severe illnesses that could interfere with the study.I have a GI ulcer not caused by MCL, confirmed by endoscopy in the last 3 months.My scans show at least one cancer spot larger than 1.5 cm or an enlarged spleen.I am between 18 and 75 years old.I have had less than 150 mg/m² of anthracycline.I do not have a bleeding disorder like hemophilia.I am not on any experimental drugs for my cancer.I am allergic to acalabrutinib, cytarabine, bortezomib, boron, or drugs used in this study.I haven't had any cancer except for certain skin, prostate, breast, or cervical cancers in the last 2 years.My kidney function, measured by creatinine clearance, is adequate.I do not have severe illnesses or recent major surgery that would affect my participation.I do not have active or uncontrolled hepatitis B or C.I have been treated with bortezomib or a BTK inhibitor before.I have not had a stroke or brain bleed in the last 6 months.I have moderate to severe nerve pain or damage.I need medication for stomach acid, like omeprazole.I've had treatment for mantle cell lymphoma, but only short-term steroids or localized radiation.I am on warfarin or a similar blood thinner.I have not had major surgery in the last 28 days or have fully recovered from it.I am HIV positive and understand there may be drug interactions with my treatment.I have not received any treatment for mantle cell lymphoma.I agree to use barrier contraception during and for 6 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (modified VR-CAP, acalabrutinib)
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.
Am I eligible to be a participant in this research study?
"To be accepted into this trial, patients must have lymphoma and their age should range from 18 to 75. The total number of participants is limited to 45 individuals."
Answered by AI
What is the current status of Doxorubicin Hydrochloride with regards to regulatory authorization?
"Our internal assessment of Doxorubicin Hydrochloride's safety rating is a 2. This evaluation was based on research from Phase 2 trials, which have indicated some evidence for its security but no data has been collected to determine efficacy."
Answered by AI
What is the sample size of this experiment?
"This trial requires 45 qualified participants. In particular, those who are eligible may enroll at either Carolinas Medical Center/Levine Cancer Institute in Charlotte, North carolina or University of Washington Medical Center - Montlake in Seattle, Washington."
Answered by AI
Is this research trial open to elderly participants?
"This trial is open to participants who are of legal age and not yet elderly, with the eligibility cutoff being 75 years old."
Answered by AI
Have any other scientific investigations been made into the usage of Doxorubicin Hydrochloride?
"NIH Clinical Center in Rockville, Maryland was the first to research doxorubicin hydrochloride in 1993. To date it has been studied extensively with a total of 3201 studies completed and 1801 currently underway; many taking place out of Charlotte, North carolina."
Answered by AI
Is the research team currently looking for new participants?
"According to the clinicaltrials.gov, this experiment is looking for volunteers and has been posted since August 3rd 2021 with a recent update on August 23rd 2022."
Answered by AI
What medical conditions are most commonly treated with Doxorubicin Hydrochloride?
"Doxorubicin Hydrochloride is the most common medication prescribed for addressing ulcerative colitis. Additionally, this pharmaceutical has seen success in managing varicella-zoster virus acute retinal necrosis, multiple myeloma, and subarachnoid block."
Answered by AI
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