At a glance

ClinicalIndex Comparison Record

Phase 2Active· 12 enrolled

Drug / intervention

Acalabrutinib +2 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04783415

NCT04783415Phase 2Active

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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)

City of Hope Medical Center·interventional·Posted Mar 5, 2021·Updated Dec 2, 2024

In Brief

A Phase 2 clinical trial evaluating Acalabrutinib, Ublituximab, and 1 other intervention for Mantle Cell Lymphoma. Active but no longer recruiting, targeting 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMantle Cell Lymphoma

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2ActiveOverdue

20222023202420252026

First PostedMar 2021

Enrollment StartMar 2021

Primary CompletionJul 2022

Study CompletionSep 2025

TodayJul 2026

First PostedMar 5, 2021

Enrollment StartMar 26, 2021

Primary CompletionJul 31, 2022

Study CompletionSep 20, 2025

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

Acalabrutinibdrug

Given PO

Ublituximabbiological

Given IV

Umbralisibdrug

Given PO