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A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
This is a Phase 2 open label, two treatment cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
Start Date
August 5, 2019
Primary Completion Date
May 22, 2022
Completion Date
May 22, 2022
Last Updated
July 24, 2023
41
ACTUAL participants
Ublituximab
DRUG
Umbralisib
DRUG
Ibrutinib
DRUG
Venetoclax
DRUG
Acalabrutinib Oral Capsule
DRUG
Lead Sponsor
TG Therapeutics, Inc.
NCT05006716
NCT07277231
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06859424