Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

Summary

Participation Requirements

Description

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...

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 in complete response wishing to attempt stem cell collection following at least 6 months of induction treatment can hold lenalidomide for up to 30 days, and restart following stem cell collection. Subjects will be monitored for Minimal Residual Disease (MRD) status in peripheral blood at baseline and completion of 12 cycles of induction treatment using Adaptive Biotechnology Clonoseq assay, and then every 4 cycles. Subjects will be followed after completing study intervention every 6 months for alternate anti-cancer therapy and survival.

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