OncRef

Clinical Trial: NCT03863184

Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Weill Medical College of Cornell University
Information Provided By:Weill Medical College of Cornell University
Last Update Posted:2026-04-28

Study Overview

Brief 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.

Official Title

A Multiple-center Phase 2 Study of Acalabrutinib-Lenalidomide-Rituximab (ALR) With an Expansion Cohort of Acalabrutinib-Lenalidomide-Obinutuzumab (ALO) in Patients With Previous Untreated Mantle Cell Lymphoma

Conditions

Mantle Cell Lymphoma

Intervention / Treatment

  • Drug: Acalabrutinib
  • Drug: Lenalidomide
  • Drug: Rituximab
  • Drug: Obinutuzumab

Other Study ID Numbers

  • 1807019439

Start Date (Actual)

2019-10-11

Primary Completion Date (Actual)

2024-04-25

Study Completion Date (Estimated)

2028-05-30

Enrollment (Actual)

37

Study Type

Interventional

Phase

Phase 2