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Acalabrutinib for High-Risk Large B-cell Lymphoma After Cellular Therapy

This study is looking at how safe and effective acalabrutinib is for people with certain types of large B-cell lymphoma. These are lymphomas that are at a very high risk of coming back after cellular therapy, like a stem cell transplant or CAR T-cell therapy. Acalabrutinib is a medicine that might help stop cancer cells from growing and spreading. The study will look at how well acalabrutinib works to keep the cancer from returning and how long people stay in remission (when the cancer is not detectable). We are also studying any side effects you might experience. This study is for people aged 18 to 70 who have already had or are having cellular therapy for their lymphoma.

Study design
This is a Phase Ib/II interventional study, meaning it looks at both safety and effectiveness. It plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long participants stay on acalabrutinib, up to 12 months from their cellular therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05256641

Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Jonsson Comprehensive Cancer Center
~24 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:Acalabrutinib

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Permanent discontinuation of acalabrutinib
Measured over Up to 12 months from cellular therapy

Conditions

Diffuse Large B-Cell Lymphoma
High-grade B-cell Lymphoma
Transformed Lymphoma
Secondary Central Nervous System Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaHigh Grade B-Cell LymphomaRecurrent Transformed Non-Hodgkin LymphomaSecondary Central Nervous System Lymphoma

NCT05256641

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, Californiastudy coordinator listed

    Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahomastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Caspian Oliai, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Vlad Kustanovitch
[email protected]
310-206-5756
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Ages 18-70 years
One of the following:
Patients undergoing autologous stem cell transplantation (ASCT) or any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy product for:
High grade B-cell lymphoma (double or triple hit) with rearrangements in bcl-2 and/or bcl-6, and rearrangement in myc
Large B-cell lymphoma with a history of secondary CNS involvement
Histologic transformation of indolent lymphoma to large B-cell lymphoma, including marginal zone lymphoma, follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), lymphoplasmacytic leukemia, or Waldenstrom macroglobulinemia
High risk international prognostic index (IPI) score 4 or 5, at diagnosis or prior to CAR T-cell leukapheresis
Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma
Eastern Cooperative Oncology Group (ECOG) 0-2
Requirements for post-ASCT and post-alloHCT participants:
Disease status of partial response (PR) or complete response (CR) prior to transplantation
Receive reduced-intensity conditioning regimen
Enrollment no later than day +90
Requirements for post-CAR T-cell therapy participants:
Disease status of PR or CR after post-CAR T-cell therapy positron emission tomography (PET)-computed tomography (CT) at 1-3 months
Enrollment no later than day +104
Ability to give full informed consent
Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib
Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty
Absolute neutrophil count (ANC) \> 500/uL (microliters)
Platelets \> 50,000/uL independent of transfusions
Hemoglobin \> 8 g/dL independent of transfusions
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
Total bilirubin =\< 1.5 x ULN, unless directly attributable to Gilbert's syndrome
Creatinine clearance \>= 60 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) =\< 1.8 mg/dL

Exclusion

Cord blood as donor source in alloHCT
New York Heart Association Class III or IV
Left ventricular ejection fraction \< 50%
Estimated glomerular filtration rate \< 30 mL/min
Concurrent long-term use of posaconazole or other strong CYP3A4 inhibitors and unable to replace with equivalent medication
Acute or chronic graft-versus-host disease (GvHD) \>= stage 3 at time of enrollment
Received packed red blood cells (pRBC) transfusion within the past 2 weeks
Received platelet transfusion within the past 1 week
Active invasive fungal infection
Active bacterial or viral infection until resolution of the infection
History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug
Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug
Refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment
Received a live virus vaccination within 28 days of first dose of study drug
Known history of infection with human immunodeficiency virus (HIV)
History of bleeding diathesis (e.g., hemophilia, von Willebrand disease)
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
Breastfeeding or pregnant
Concurrent participation in another therapeutic clinical trial

What this trial measures

  • Permanent discontinuation of acalabrutinibUp to 12 months from cellular therapy

    Tolerability will be determined by the number of patients who permanently discontinue acalabrutinib within 12 months from cellular therapy due to intolerance. The proportion of patients with acalabrutinib discontinuation will be reported along with 95% and 90% confidence intervals.