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 (Jun 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
Treatments studied
Immunotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07029737 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CCND1?
Yes, CCND1 overexpression is a required biomarker for enrollment.
Does this trial require IGH?
Yes, IGH t(11;14)(q13;q32) translocation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 130 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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