OncoMatch/Clinical Trials/NCT04566887
Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma
Is NCT04566887 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Acalabrutinib and R-CHOP chemotherapy for mantle cell lymphoma.
Treatment: Acalabrutinib · R-CHOP chemotherapy — This is a multicenter, open-label, non-randomized, phase II clinical trial conducted in Canada. The purpose of the study is to determine the remission rate of acalabrutinib in combination with R-CHOP in patients with previously untreated mantle cell lymphoma prior to autologous stem cell transplantation. This study is composed of 2 cohorts, A and B. In Cohort A all patients will receive six cycles of R-CHOP chemotherapy together with continuous acalabrutinib at the standard dose twice per day orally. All patients will undergo response assessment at the end of six cycles of R-CHOP + acalabrutinib with CT scan, PET/CT scan, and bone marrow biopsy. Responding patients will proceed with stem cell mobilization, apheresis, and processing. Following ASCT, patients will receive standard maintenance rituximab every 3 months for 2 years. Enrollment for Cohort A component of the study has been completed. Cohort B, involves using acalabrutinib with R-CHOP (same as Group A) but without an autologous stem cell transplant (ASCT) as part of the regimen. The study doctors hope to evaluate how participants respond to the treatment in terms of the time between treatment initiation and time when stable disease is achieved. The enrollment for cohort B is currently ongoing.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BCR inhibitor
Prior exposure to a BCR inhibitor (eg, BTK inhibitors, phosphoinositide-3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor
Cannot have received: BCL-2 inhibitor
Prior exposure to a BCR inhibitor (eg, BTK inhibitors, phosphoinositide-3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor
Lab requirements
Blood counts
ANC <1.0 x10^9/L (subjects with bone marrow involvement by lymphoma are eligible regardless of ANC); Platelets <50 x10^9/L (subjects with bone marrow involvement by lymphoma are eligible regardless of platelet count); PT/INR >2 times the upper limit of normal in the absence of anticoagulants and/or PTT >2 times the upper limit of normal in the absence of anticoagulants
Kidney function
Creatinine clearance <30 mL/min
Liver function
Total serum bilirubin ≥1.5 times the upper limit of normal, unless directly attributable to Gilbert's syndrome (or >3 times for documented hepatic involvement by lymphoma), AST and ALT >3 times the upper limit of normal (or >5 times for documented hepatic involvement by lymphoma)
ANC <1.0 x10^9/L (subjects with bone marrow involvement by lymphoma are eligible regardless of ANC); Platelets <50 x10^9/L (subjects with bone marrow involvement by lymphoma are eligible regardless of platelet count); Total serum bilirubin ≥1.5 times the upper limit of normal, unless directly attributable to Gilbert's syndrome (or >3 times for documented hepatic involvement by lymphoma), AST and ALT >3 times the upper limit of normal (or >5 times for documented hepatic involvement by lymphoma); Creatinine clearance <30 mL/min; PT/INR >2 times the upper limit of normal in the absence of anticoagulants and/or PTT >2 times the upper limit of normal in the absence of anticoagulants
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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