Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma
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|ClinicalTrials.gov Identifier: NCT04508647|
Recruitment Status : Not yet recruiting
First Posted : August 11, 2020
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone Lymphoma Follicular Lymphoma||Drug: Ublituximab Drug: Umbralisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||December 2023|
Treatment-Naive Stage II (non-contiguous), Stage III, Stage IV FL + MZL will receive Ublituximab 900mg IV weekly x 4 doses. End of treatment assessment 8 weeks post last dose of single agent ublituximab will be performed. Patients who achieve less than a complete response will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1,8 and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles)
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.
Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
- Best Complete response (CR) rates at anytime during treatment with single agent or combination therapy [ Time Frame: 2 years ]as defined by the Lugano response Criteria for NHL (Cheson 2014)
- Overall response rates (ORR) in the entire cohort [ Time Frame: 2 years ]as defined by the Lugano response Criteria for NHL (Cheson 2014)
- Regimen Toxicities [ Time Frame: 2 years ]as per Common Terminology Criteria for Adverse Events V5.0, collected by medical staff
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508647
|Contact: Derek Schatzfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Contact: Derek Schatz 720-848-0628 email@example.com|
|Principal Investigator: Manali Kamdar|