CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Ublituximab +1 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/NCT04508647
NCT04508647Phase 2Completed
CompareCT.gov

Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response

University of Colorado, Denver·interventional·Posted Aug 11, 2020·Updated Mar 21, 2024

In Brief

A Phase 2 clinical trial evaluating Ublituximab and Umbralisib for Marginal Zone Lymphoma and Follicular Lymphoma. Completed, enrolled 4 participants across 1 site.

Detailed Summary

This is an open-label, Phase II interventional study in order to assess efficacy and safety of single agent ublituximab as initial therapy for FL (Follicular lymphoma) and MZL (Marginal zone lymphoma ) with response driven addition of umbralisib for suboptimal response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMarginal Zone Lymphoma, Follicular Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 11, 2020
Enrollment StartNov 23, 2020
Primary CompletionJul 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.9 years ago

Interventions

Ublituximabdrug

Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines. During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes. During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.

Umbralisibdrug

Umbralisib will be administered orally once daily within 30 minutes of starting a meal.