Actively Recruiting
Acalabrutinib Maintenance Following Cellular Therapy for Large B-Cell Lymphoma Patients at Very High Risk for Relapse
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-10
24
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of maintenance treatment with acalabrutinib for patients who have large B-cell lymphoma and are at very high risk of the cancer returning after cellular therapy. This phase Ib/II trial aims to evaluate how well acalabrutinib works in preventing relapse, how long remission lasts after treatment, and survival rates. The study also looks at side effects and how the treatment affects immune cells and tumor DNA. Patients are assigned to one of three groups based on their prior cellular therapy: those who had allogeneic hematopoietic cell transplantation begin acalabrutinib orally once daily from day 90 and then twice daily until day 365; those who had autologous stem cell transplantation start once daily from day 60 and then twice daily from day 74 until day 365; and patients who received CAR T-cell therapy begin twice daily treatment anytime between days 28 to 104 until day 365. Treatment continues unless the cancer progresses or side effects become unacceptable. Participants will be monitored regularly during the treatment period, with follow-up visits 30 days after completing the study drug. Researchers will track the need to stop the drug permanently, disease progression, survival, response rates, dose changes, and side effects including graft-versus-host disease and blood-related toxicities. The study lasts up to one year of treatment with long-term follow-up for up to five years to assess ongoing outcomes.
CONDITIONS
Brief Title
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18-70 years
- Diagnosis of high grade B-cell lymphoma with specific genetic rearrangements or large B-cell lymphoma with secondary CNS involvement
- Histologic transformation from indolent lymphoma to large B-cell lymphoma
- High risk international prognostic index score 4 or 5 at diagnosis or before CAR T-cell leukapheresis
- Undergoing autologous stem cell transplantation, CAR T-cell therapy, or allogeneic hematopoietic cell transplantation for large B-cell lymphoma
- ECOG performance status 0-2
- Partial or complete response disease status before transplantation or post-CAR T-cell therapy
- Reduced-intensity conditioning regimen for transplant patients
- Enrollment by day 90 post-transplant or day 104 post-CAR T-cell therapy
- Ability to provide informed consent
- Use of effective contraception for sexually active females who can bear children
- Able to swallow capsules or tablets
- Adequate blood counts and organ function as specified
You will not qualify if you...
- Use of cord blood as donor source in allogeneic transplantation
- New York Heart Association Class III or IV heart failure
- Left ventricular ejection fraction below 50%
- Estimated glomerular filtration rate below 30 mL/min
- Long-term use of posaconazole or strong CYP3A4 inhibitors if not replaceable
- Acute or chronic graft-versus-host disease stage 3 or higher at enrollment
- Recent blood transfusions within specified times
- Active invasive fungal, bacterial, or viral infections
- History or ongoing progressive multifocal leukoencephalopathy
- Use of investigational drugs within 30 days before study drug
- Major surgery within 30 days before study drug
- Conditions affecting swallowing or absorption of study drug
- Live virus vaccination within 28 days before study drug
- Known HIV infection
- History of bleeding disorders
- Use of warfarin or equivalent anticoagulants
- Treatment with strong CYP3A inhibitors or inducers near study start
- Pregnancy or breastfeeding
- Participation in another therapeutic clinical trial concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive maintenance acalabrutinib following cellular therapy for large B-cell lymphoma. Depending on the group, treatment starts between days 28 and 90 post-therapy and continues until day 365 unless there is disease progression or unacceptable toxicity.
Visits as per dosing schedule from day 28 to day 365
Duration - 30 days
After completing acalabrutinib treatment, participants are followed up to assess safety and disease status.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
3
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73190
Not Yet Recruiting
Research Team
V
Vlad Kustanovitch
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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