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NCT04002947 · ClinicalTrials.gov record · last posted 2026-08-13

Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

StatusRecruiting
PhasePhase 2
Started2019-08-05
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from the ClinicalTrials.gov record
Background: Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate. Objective: To see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma. Eligibility: People ages 18 and older with an aggressive B-cell lymphomas that have not been treated Design: Participants will be screened with: Blood and urine tests Physical exam Medical history Tumor biopsy Bone marrow biopsy: A needle will remove marrow from the participant s hipbone. Lumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal. Imaging scans Participants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles. Participants may have 4 doses of another drug injected into their spinal fluid. Participants will have repeats of the screening tests throughout the study. Participants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.

Protocol amendment history 2 changes detected by DataLookout

2026-06-18
critical
Primary completion pushed: 2026-05-31 → 2027-05-31
2026-06-18
minor
Completion pushed: 2030-03-31 → 2031-03-31
Trial Details
NCT Number NCT04002947
Lead Sponsor National Cancer Institute (NCI)
Conditions Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, NHL
Enrollment 132 participants
Start Date 2019-08-05
Primary Completion 2027-05-31 (estimated)
Study Completion 2031-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-13