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NCT03379051 Clinical Trial

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03379051
Other study ID # U2-VEN-109
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date March 27, 2018
Est. completion date June 16, 2022

Study information
Verified date August 2022
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Recruitment information / eligibility
Status Terminated
Enrollment 78
Est. completion date June 16, 2022
Est. primary completion date May 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma - Refractory to or relapsed after at least 1 prior treatment regimen - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: - Any major surgery, chemotherapy or immunotherapy within the last 21 days - Known hepatitis B virus, hepatitis C virus or HIV infection - Known histological transformation from CLL to an aggressive lymphoma (Richter's)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Venetoclax
BCL-2 Inhibitor
• Umbralisib
PI3K-Delta Inhibitor
Biological:
• Ublituximab
Glycoengineered Anti-CD20 mAb
Drug:
• Lenalidomide
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Chicago Illinois
United States TG Therapeutics Investigational Trial Site Cleveland Ohio
United States TG Therapeutics Investigational Trial Site Rochester New York

Sponsors (2)
Lead Sponsor Collaborator
TG Therapeutics, Inc. James P. Wilmot Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine Acceptable Adverse Events That Are Related to Treatment 12 months
Secondary Overall Response and Complete Remission Rate 12 months
Secondary Minimum Residual Disease (MRD) 12 months
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