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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib + Rituximab and CAR T-Cell Therapy for Mantle Cell Lymphoma
Phase < 1
Recruiting
Led By Preetesh Jain, MD, PHD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days after car t-cell infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a new combination of drugs can help control mantle cell lymphoma, a type of cancer.
Who is the study for?
This trial is for adults with newly diagnosed high-risk mantle cell lymphoma who haven't had treatment before. They must have specific genetic markers, be able to swallow pills, and have a good performance status (able to carry out daily activities). Women should not be pregnant and must use birth control. People can't join if they've had other cancers needing active treatment, certain heart or blood conditions, or are HIV positive.
What is being tested?
The study tests a combination of acalabrutinib and rituximab followed by brexucabtagene autoleucel therapy in patients with untreated high-risk mantle cell lymphoma. The goal is to see if this regimen controls the disease better than current treatments.
What are the potential side effects?
Possible side effects include nausea, diarrhea, headaches from acalabrutinib; infusion reactions like fever or chills from rituximab; and flu-like symptoms, low blood counts leading to infection risk or bleeding problems from brexucabtagene autoleucel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days after car t-cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days after car t-cell infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Brexucabtagene Autoleucel (Part 2)Experimental Treatment3 Interventions
Participants will have a procedure called leukapheresis to collect enough T cells.
Group II: Acalabrutinib and Rituximab (Part 1)Experimental Treatment4 Interventions
Participants may receive acalabrutinib and rituximab for up to 12 cycles. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2080
Rituximab
1999
Completed Phase 4
~2990
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Acerta Pharma, LLCOTHER
6 Previous Clinical Trials
312 Total Patients Enrolled
Kite, A Gilead CompanyIndustry Sponsor
44 Previous Clinical Trials
3,960 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 6 weeks.I am currently on medication for an infection.I do not have uncontrolled diabetes, COPD, renal failure, psychiatric illness, or other serious conditions.I haven't had major surgery in the last 28 days.I am 18 years old or older.I have a serious stomach or intestinal ulcer.I am eligible for CAR T-cell therapy.I have a bleeding disorder or am currently experiencing active bleeding.I am not pregnant and use effective birth control.I am not taking any strong medications that affect liver enzymes.I am not taking high doses of corticosteroids for a long time.I have had symptoms of a blood clot in my leg or lung in the past 6 months.I was diagnosed with an autoimmune disease in the last 2 years.My cancer is only in my bone marrow or GI tract, or it can't be measured.My cancer responded to hormone therapy alone or did not respond at all.My lymphoma has spread to my brain or I might have PML.I can carry out all my usual activities without help.My heart condition meets specific health criteria.I have trouble swallowing pills or have a serious stomach condition.I have a history of or currently have a brain or nervous system disorder.I have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.My heart has been cleared for specific cancer treatments.I am HIV positive.I have a condition that affects how my body absorbs nutrients.I need specific blood-thinning treatments.I do not have any life-threatening illnesses or severe organ problems.My MCL is considered high risk based on its specific features.My lymphoma is confirmed with specific tests showing CD20 and certain genetic features.I have high-risk MCL and haven't received any treatment, but I'm eligible for AR and CART cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib and Rituximab (Part 1)
- Group 2: Brexucabtagene Autoleucel (Part 2)
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.
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