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OncoMatch/Clinical Trials/NCT05256641

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

Is NCT05256641 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Acalabrutinib for diffuse large b-cell lymphoma.

Phase 1/2RecruitingJonsson Comprehensive Cancer CenterNCT05256641Data as of Jun 2026

Treatment: AcalabrutinibThis 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Acalabrutinib

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Primary Central Nervous System Lymphoma

Biomarker criteria

Required: BCL2 rearrangement

Required: BCL6 rearrangement

Required: MYC rearrangement

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 70

Prior therapy

Must have received: autologous stem cell transplant

Patients undergoing autologous stem cell transplantation (ASCT)

Must have received: CAR-T cell therapy

any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy product

Must have received: allogeneic hematopoietic cell transplantation

Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma

Lab requirements

Blood counts

Absolute neutrophil count (ANC) > 500/uL; Platelets > 50,000/uL independent of transfusions; Hemoglobin > 8 g/dL independent of transfusions

Kidney function

Creatinine clearance >= 60 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) <= 1.8 mg/dL

Liver function

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

Cardiac function

Left ventricular ejection fraction >= 50%

Absolute neutrophil count (ANC) > 500/uL; 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; Left ventricular ejection fraction >= 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
  • University of California Davis Comprehensive Cancer Center · Sacramento, California
  • University of Oklahoma · Oklahoma City, Oklahoma

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05256641 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received autologous stem cell transplant and CAR-T cell therapy.

Does this trial require BCL2?

Yes, BCL2 rearrangement is a required biomarker for enrollment.

Does this trial require BCL6?

Yes, BCL6 rearrangement is a required biomarker for enrollment.

Does this trial require MYC?

Yes, MYC rearrangement is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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