NCT04508647

Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on overall reporting in low tumor burden FL and MZL, CR rate of at least 30% was achieved when single agent rituximab was used in these subsets. The investigators assume that by administering ublituximab (both as a single agent and in combination with umbralisib for individuals who fail to achieve a CR \[Complete response\] with the single agent), the CR rate will increase to 50%. Efficacy will be assessed using the proportion of patients treated with ublituximab alone or with ublituximab administered in combination who have a complete response. Thus, the investigators will test the efficacy of ublituximab using a difference in proportions design by comparing an expected study population control rate of 50% to the comparison proportion being determined by the historical control CR rate of 30%. In other words, the null hypothesis is that the true response rate is 30%, and it will be formally tested against a one-sided alternative that the response rate is 50%.

Conditions

• Marginal Zone Lymphoma
• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Ublituximab	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.
DRUG	Umbralisib	Umbralisib will be administered orally once daily within 30 minutes of starting a meal.

Timeline

• Start date: 2020-11-23
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2020-08-11
• Last updated: 2024-03-21
• Results posted: 2023-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study