Actively Recruiting
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-10
24
Participants Needed
3
Research Sites
262 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
This phase Ib/II trial studies the side effects and efficacy of maintenance acalabrutinib following cellular therapy in treating patients with large B-cell lymphoma at very high risk of the cancer coming back. Acalabrutinib is a small molecular inhibitor that may interfere with the ability of cancer cells to grow and spread.
CONDITIONS
Official 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
- Diagnosed with one of the following: high-grade B-cell lymphoma with specific genetic rearrangements, large B-cell lymphoma with secondary central nervous system involvement, histologic transformation of indolent lymphoma to large B-cell lymphoma, or high risk international prognostic index (IPI) score 4 or 5
- Undergoing autologous stem cell transplantation (ASCT), FDA-approved CAR T-cell therapy, or allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- For post-ASCT and post-alloHCT participants: disease status of partial or complete response before transplantation, received reduced-intensity conditioning, enrolled no later than day +90
- For post-CAR T-cell therapy participants: disease status of partial or complete response at 1-3 months after therapy, enrolled no later than day +104
- Ability to provide full informed consent
- Female participants who can bear children must agree to use highly effective contraception during treatment and for 2 days after last dose
- Willing and able to participate in all study evaluations and procedures, including swallowing capsules and tablets
- Absolute neutrophil count above 500/uL
- Platelets above 50,000/uL regardless of transfusions
- Hemoglobin above 8 g/dL regardless of transfusions
- Serum AST and ALT less than or equal to 3 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times the upper limit of normal unless due to Gilbert's syndrome
- Creatinine clearance of at least 60 mL/min and serum creatinine less than or equal to 1.8 mg/dL
You will not qualify if you...
- Cord blood used as donor source in allogeneic hematopoietic cell 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 other strong CYP3A4 inhibitors without possible replacement
- Acute or chronic graft-versus-host disease stage 3 or higher at enrollment
- Received red blood cell transfusion within 2 weeks prior
- Received platelet transfusion within 1 week prior
- Active invasive fungal infection
- Active bacterial or viral infection not resolved
- History or ongoing progressive multifocal leukoencephalopathy (PML)
- Received investigational drug within 30 days or 5 half-lives before first study drug dose
- Major surgery within 30 days before first study drug dose without full recovery
- Severe nausea, vomiting, swallowing difficulties, malabsorption, or gastrointestinal conditions affecting study drug absorption
- Received live virus vaccination within 28 days before first study drug dose
- Known HIV infection
- History of bleeding disorders like hemophilia or von Willebrand disease
- Need for anticoagulation with warfarin or similar vitamin K antagonists
- Need for treatment with strong CYP3A inhibitors or inducers near study start
- Pregnant or breastfeeding
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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