Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

Summary

This is a multi-arm phase 2 study to evaluate the preliminary evidence of efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) and acalabrutinib, lenalidomide and obinutuzumab (ALO) in previously untreated mantle cell lymphoma. The study includes an induction phase consisting of 12 cycles of ALR or ALO. Responding subjects will be eligible to enter a maintenance phase. Subjects will continue maintenance ALR or ALO 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.

Timeline

Start

2019-10-11

Primary completion

2024-04-25

Completion

2028-05-30

Publications

• Ruan J, Bond DA, Shah B, Allan JN, Rutherford SC, Gribbin C, Chen Z, Bhinder B, Tam W, Rossi D, Xiang J, Hobbie B, Harbhajan M, Sahni TK, Chen GZ, Sigouros M, Inghirami G, Chen-Kiang S, Elemento O, Maddocks K, Leonard JP, Martin P. MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma. Blood Adv. 2026 Feb 24;10(4):1381-1394. doi: 10.1182/bloodadvances.2025017760.

Drugs

Indications