OncoMatch/Clinical Trials/NCT05820841
Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
Is NCT05820841 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including R-miniCHOP + Acalabrutinib and R-miniCHOP for large b-cell lymphoma.
Treatment: R-miniCHOP + Acalabrutinib · R-miniCHOP — The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib. Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 positive
Histologically proven, previously untreated CD20+ diffuse large B-cell lymphoma
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
Allowed: IRF4 rearrangement
large B-cell lymphoma with IRF4 rearrangement
Disease stage
Required: Stage I WITH BULK ≥7.5CM, II, III, IV (Ann Arbor)
Disease Stage I with bulk ≥7.5cm, II, III or IV according to Ann Arbor Classification
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BTK inhibitor
Prior exposure to a BTK inhibitor
Cannot have received: anthracycline
Exception: prior anthracycline use <300 mg/m2 allowed
Prior anthracycline use ≥300 mg/m2
Cannot have received: lymphoma therapy
Exception: steroid (max. total dose of 1000mg), vincristine (max. 1 mg once) or rituximab (max. 375mg/m2) prephase allowed
Already initiated lymphoma therapy except for steroid (max. total dose of 1000mg), vincristine (max. 1 mg once) or rituximab (max. 375mg/m2) prephase
Cannot have received: investigational drug
Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500 cells/µl or platelet count ≥ 100,000/µl unless directly attributable to lymphoma.
Kidney function
Estimated creatinine clearance of ≥30 mL/min, calculated by Cockcroft-Gault (using actual body weight), or serum creatinine ≤2.5 x ULN.
Liver function
Serum AST and ALT ≤3 x upper limit of normal (ULN) unless directly attributable to lymphoma. Total bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert's syndrome or lymphoma.
Meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥ 1500 cells/µl or platelet count ≥ 100,000/µl unless directly attributable to lymphoma. Serum AST and ALT ≤3 x upper limit of normal (ULN) unless directly attributable to lymphoma. Total bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert's syndrome or lymphoma. Estimated creatinine clearance of ≥30 mL/min, calculated by Cockcroft-Gault (using actual body weight), or serum creatinine ≤2.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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