OncoMatch/Clinical Trials/NCT04002947
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
Is NCT04002947 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Rituximab and DA-EPOCH for non-hodgkin's lymphoma.
Treatment: DA-EPOCH · Rituximab · CHOP · Acalabrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Allowed: MYC rearrangement
High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL2 rearrangement
High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL6 rearrangement
High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
Allowed: ALK rearrangement
ALK+ large B-cell lymphoma
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-cancer treatment for DLBCL
Exception: Short course of corticosteroids (<7 days) for acute issues prior to study enrollment are permitted.
Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (<7 days) for acute issues prior to study enrollment are permitted.
Lab requirements
Blood counts
absolute neutrophil count >=1,000/mcL; hemoglobin >= 8 g/dL (transfusions permitted to meet criteria); Platelets >= 75,000/mcL (transfusions not permitted unless bone marrow involvement)
Kidney function
Serum creatinine <= 2.0 mg/dL OR Creatinine clearance >=40 mL/min/1.73 m2 for patients with creatinine levels above 2 mg/dL
Liver function
total bilirubin <= 1.5 X institutional ULN (or <= 3 X institutional ULN for patients with documented Gilberts syndrome or cholestatic obstruction or involvement by lymphoma); AST(SGOT)/ALT(SGPT) <= 3 X institutional ULN (<= 5 x ULN for patients with cholestatic obstruction or involvement by lymphoma)
Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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