Status:
RECRUITING
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Diffuse Large B-Cell Lymphoma
High-grade B-cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 com...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the safety and tolerability of maintenance acalabrutinib following cellular therapy in participants with large B-cell lymphoma at very high risk for relapse. SECON...
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
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05256641
Start Date
January 23 2023
End Date
January 31 2027
Last Update
November 10 2025
Active Locations (3)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73190