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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Lenalidomide + Rituximab for Follicular Lymphoma
Phase 2
Waitlist Available
Led By Paolo Strati
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI)
Have had no prior systemic treatment for lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with a certain type of lymphoma. The drugs work in different ways to stop the growth of cancer cells.
Who is the study for?
This trial is for adults with CD20 positive stage III-IV, grade 1-3a follicular lymphoma who haven't had prior systemic treatment. They must have measurable disease, meet certain criteria for starting treatment, and be in good physical condition with adequate organ function. Participants need to use effective birth control and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests a combination of acalabrutinib (blocks enzymes needed for cancer cell growth), lenalidomide (chemotherapy that kills or stops tumor cells from dividing), and rituximab (monoclonal antibody against cancer cells). It aims to see how well these drugs work together in controlling this type of lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as infusion reactions, blood disorders like anemia or clotting problems, liver issues signaled by abnormal enzyme levels, fatigue, infections due to lowered white blood cell counts, and possible digestive disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that is at least 2 cm large, confirmed by imaging tests.
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I have not received any treatment for lymphoma before.
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My liver and kidney tests are within required limits.
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My lymphoma is CD20 positive and is grade 1, 2, or 3a.
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I am registered in the Revlimid REMS program.
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I am a woman who can have children and my pregnancy test was negative.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My condition is in stage III or IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission rate
Secondary outcome measures
Duration of response
Frequency of treatment-emergent AEs requiring study drug discontinuation or dose reduction
Frequency, severity, and relatedness of treatment-emergent adverse events (AEs)
+4 moreOther outcome measures
Alteration in immune cell subsets
Cell free circulating deoxyribonucleic acid (DNA)
Side 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: Treatment (acalabrutinib, lenalidomide, rituximab)Experimental Treatment3 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Beginning cycle 2, patients receive lenalidomide PO QD on days 1-21 and rituximab IV on days 1, 8, 15, and 22 of cycle 2 and day 1 of subsequent cycles. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Acalabrutinib
2020
Completed Phase 2
~2050
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,156 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,429 Total Patients Enrolled
Paolo StratiPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that is at least 2 cm large, confirmed by imaging tests.I do not have any major heart conditions.I have not received any treatment for lymphoma before.I am not pregnant, breastfeeding, or taking experimental drugs.I have not taken certain medications that are not allowed.My liver and kidney tests are within required limits.My brain or spinal cord cancer has been in remission for more than 6 months.I cannot swallow pills easily due to my stomach or intestine issues.I do not have bleeding, neurological conditions, or recent vaccinations that would exclude me.I have been cancer-free from another type for 5 years or more.My lymphoma is CD20 positive and is grade 1, 2, or 3a.I do not have any excluded infectious or medical conditions.My condition is a type of aggressive lymphoma.I haven't had recent surgery, don't use steroids, expect to live more than a few months, and don't have severe nerve pain.I am not taking any medications that are excluded in this trial.My condition is Grade 3b Follicular Lymphoma.I do not have HIV, active hepatitis B or C, or any uncontrolled infections.I am registered in the Revlimid REMS program.I am a woman who can have children and my pregnancy test was negative.I can take care of myself and am up and about more than 50% of my waking hours.I cannot switch to H2-receptor antagonists.My condition is in stage III or IV.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib, lenalidomide, rituximab)
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 is the government's stance on Acalabrutinib?
"Acalabrutinib's safety is based primarily on Phase 2 trial data, which means that while there is some evidence to support its safety, there is none for its efficacy."
Answered by AI
What is the estimated amount of people who will be participating in this research project?
"That is correct, the online clinicaltrials.gov registry indicates that this research study is actively looking for participants. The trial was first advertised on 16/7/2020 and underwent its most recent update on 31/7/2022. In total, the investigators seek to enroll 24 individuals at a single medical facility."
Answered by AI
Are applications for this research being accepted at the moment?
"Yes, this study is still recruiting patients. The listing on clinicaltrials.gov shows that the trial was posted on July 16th 2020 and updated as recently as July 31st, 2022."
Answered by AI
What are some of the primary benefits of Acalabrutinib?
"Acalabrutinib is a medication used to treat chronic lymphocytic leukemia, but it can also help patients with diffuse large b-cell lymphoma (dlbcl) and kidney failure. If you have had two prior systemic chemotherapy regimens, this drug may be right for you."
Answered by AI
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