Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase II
Principal Investigator: Shah, Bijal
A Multiple-center Phase 2 Study of Acalabrutinib-Lenalidomide-Rituximab in Patients with Previous Untreated Mantle Cell Lymphoma
This is a single-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR until disease progression, development of unacceptable toxicity, or voluntary withdrawal. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.
To determine the peripheral blood minimum residual disease (MRD)-negative complete response (CR) rate of the combination of ALR at the conclusion of 12 cycles of induction therapy. Secondary Objectives: Safety and tolerability of the combination Best overall response rate Complete response rate Progression free survival (time frame up to 2 years) Overall survival (time frame up to 2 years)
Chemotherapy (NOS); Therapy (NOS)
ACP-196 (Acalabrutinib); Acalabrutinib (); CC-5013 (Lenalidomide); Lenalidomide (Revlimid); Obinutuzumab (); Rituxan (rituximab); rituximab ()
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