Your session is about to expire
← Back to Search
Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Lenalidomide + Rituximab for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Jia Ruan, M.D., Ph.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All subjects must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®
ECOG performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for mantle cell lymphoma, which is a cancer of the lymph nodes. The treatment consists of 12 cycles of three drugs, after which responding patients can enter a maintenance phase. The goal is to see if the treatment is effective and safe.
Who is the study for?
This trial is for adults with untreated mantle cell lymphoma who need treatment, have good liver and kidney function, can follow the study schedule, and agree to use birth control. People with certain heart conditions, active infections like HIV or hepatitis B/C, recent major surgery, other cancers within 5 years (except some skin or localized cancers), or those on specific medications are excluded.Check my eligibility
What is being tested?
The trial tests a combination of acalabrutinib, lenalidomide and rituximab (ALR) in patients with untreated mantle cell lymphoma over an induction phase of 12 cycles followed by maintenance therapy until disease progression or unacceptable side effects occur. The effectiveness and safety of this regimen will be monitored throughout the study.See study design
What are the potential side effects?
Possible side effects include reactions to infusions such as fever or chills; blood disorders like low white cells increasing infection risk; digestive issues; fatigue; allergic reactions; potential bleeding problems due to aspirin required for anticoagulation; and risks associated with long-term use of lenalidomide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am registered and can follow the Revlimid REMS program.
Select...
I can take care of myself and do some daily activities.
Select...
I have not had any drug treatments for lymphoma.
Select...
I am 18 years old or older.
Select...
My tumor is larger than 1.5 cm or my spleen is affected.
Select...
My diagnosis is mantle cell lymphoma confirmed by tissue analysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peripheral blood minimum residual disease (MRD)-negative complete response (CR) rate of the combination of acalabrutinib + lenalidomide + rituximab at the conclusion of 12 cycles of induction therapy
Secondary outcome measures
Complete response rate
Overall response rate
Overall survival
+3 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: ALR in CombinationExperimental Treatment3 Interventions
Acalabrutinib, lenalidomide, and rituximab in combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,201 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,260 Previous Clinical Trials
288,594,117 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,493 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects how my body absorbs food.I am registered and can follow the Revlimid REMS program.I am at high risk for blood clots and refuse to take preventive medication.I can take care of myself and do some daily activities.I have not had any drug treatments for lymphoma.I do not have a bleeding disorder like hemophilia.I am taking medication for stomach acid, like omeprazole.I agree to follow strict birth control and pregnancy testing rules if I'm of childbearing age.My cancer has blastoid features.I have HIV or hepatitis but am under treatment.I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.I have not had major surgery in the last 28 days or have fully recovered from it.My cancer has spread to my brain.I have been treated with a BTK inhibitor before.I am 18 years old or older.I am taking warfarin or similar blood thinners within a week of starting the study drug.My tumor is larger than 1.5 cm or my spleen is affected.You have had a severe skin reaction called toxic epidermal necrolysis or Stevens-Johnson syndrome in the past.I do not have an ongoing serious infection that isn't getting better with treatment.I have taken corticosteroids recently, but not more than 20 mg/day of prednisone or its equivalent.I need treatment with a strong medication that affects liver enzymes.My diagnosis is mantle cell lymphoma confirmed by tissue analysis.I do not have any health issues that would stop me from joining the study.I have been cancer-free for over 5 years, except for certain skin, cervical, breast, or prostate cancers.I can take daily aspirin or a substitute if I'm allergic.I haven't used any experimental drugs or therapies in the last 28 days.I have uncontrolled AIHA or ITP.I have not had a stroke or brain bleed in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: ALR in Combination
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.
Has Acalabrutinib been given the green light from the Food and Drug Administration?
"Acalabrutinib's safety is assessed as a 2 on our scale because though there are some studies that attest to its security, there are none yet confirming its effectiveness."
Answered by AI
What symptoms does Acalabrutinib typically alleviate?
"Acalabrutinib is a commonly used pharmaceutical for treating diffuse large b-cell lymphoma (DLBCL), though it can also be effective in managing other ailments such as patients who have had at least two previous systemic chemotherapy treatments, B-Cell Lymphomas and Polyangium."
Answered by AI
How large is the cohort participating in this research project?
"Correct. According to clinicaltrials.gov, this medical study which was originally advertised on October 11th 2019 is still actively recruiting patients. 24 participants must be recruited from a single trial site."
Answered by AI
Are there still opportunities for participants in this research trial?
"According to the clinicaltrials.gov data, this research trial is currently open for recruitment with a posting date of October 11th 2019 and an edit on October 17th 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger