OncoMatch/Clinical Trials/NCT07029737
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Is NCT07029737 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Acalabrutinib + R-CHOP standard of care and Acalabrutinib combination with Rituximab for mantle-cell lymphoma.
Treatment: Acalabrutinib + R-CHOP standard of care · Acalabrutinib combination with Rituximab · Acalabrutinib monotherapy — This is a single-arm, open-label, multicenter, non-indication seeking phase II trial to describe the efficacy and safety of patients with mantle cell lymphoma (MCL) receiving acalabrutinib in combination with R-CHOP for the front-line treatment of MCL in Spain. Acalabrutinib will be administered until disease progression if medically appropriate, along with R-CHOP based on institutional standards. After 6 cycles of acalabrutinib in combination with R-CHOP, subjects who tolerate treatment and not progressing, will then receive monotherapy acalabrutinib. In addition, subjects who achieve a response (PR or greater) will receive maintenance rituximab every other 28-day cycle for a maximum of 12 additional doses. Thereafter, subjects receive monotherapy acalabrutinib until disease progression or treatment discontinuation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
overexpression of cyclin D1 in association with other relevant markers
Required: IGH t(11;14)(q13;q32) translocation
chromosome translocation t(11;14)(q13;q32)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) <1.0 x 10^9/L or platelet count <75 x 10^9/L; for subjects with disease involvement in the bone marrow, ANC <0.75 x 10^9/L or platelet count <50 x 10^9/L. Subjects will only be considered eligible if peripheral blood counts can be maintained independent of growth factors or transfusions during the screening period.
Kidney function
Estimated creatinine clearance of <30 mL/min, calculated using the formula of Cockcroft and Gault.
Liver function
Total bilirubin >1.5 x upper limit normal (ULN) unless other reason known; or aspartate aminotransferase (AST) or alanine transaminase (ALT) >2.5 x ULN.
Cardiac function
Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
Absolute neutrophil count (ANC) <1.0 x 10^9/L or platelet count <75 x 10^9/L; for subjects with disease involvement in the bone marrow, ANC <0.75 x 10^9/L or platelet count <50 x 10^9/L. Total bilirubin >1.5 x upper limit normal (ULN) unless other reason known; or aspartate aminotransferase (AST) or alanine transaminase (ALT) >2.5 x ULN. Estimated creatinine clearance of <30 mL/min. Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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