OncRef

Clinical Trial: NCT04783415

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:City of Hope Medical Center
Information Provided By:City of Hope Medical Center
Last Update Posted:2026-10-06

Study Overview

Brief Summary

This phase II trial studies the effects of acalabrutinib, umbralisib, and ublituximab in treating previously untreated mantle cell lymphoma. Acalabrutinib and umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and umbralisib with ublituximab may work better in treating mantle cell lymphoma.

Official Title

A Phase II Study of BTK Inhibitor Acalabrutinib and PI3Kδ Inhibitor Umbralisib in Combination With Ublituximab (AU2) in Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

Conditions

Mantle Cell Lymphoma

Intervention / Treatment

  • Drug: Acalabrutinib
  • Biological: Ublituximab
  • Drug: Umbralisib

Other Study ID Numbers

  • 20459
  • NCI-2021-00498
  • 20459
  • P30CA033572

Start Date (Actual)

2021-03-26

Primary Completion Date (Actual)

2022-07-31

Study Completion Date (Estimated)

2027-07-13

Enrollment (Actual)

12

Study Type

Interventional

Phase

Phase 2