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

Phase 1

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma
• Interventions: Drug: Venetoclax; Drug: Umbralisib; Biological: Ublituximab; Drug: Lenalidomide

• Registration Number: NCT03379051
• Lead Sponsor: TG Therapeutics, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Study Start: 2018-03-27
• Primary Completion: 2022-05-26
• Study Completion: 2022-06-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ublituximab + Umbralisib + Venetoclax	Ublituximab	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
Ublituximab + Umbralisib + Lenalidomide	Ublituximab	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Ublituximab + Umbralisib + Venetoclax	Venetoclax	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
Ublituximab + Umbralisib + Venetoclax	Umbralisib	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
Ublituximab + Umbralisib + Lenalidomide	Umbralisib	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Ublituximab + Umbralisib + Lenalidomide	Lenalidomide	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days

Primary Outcome Measures

Name	Time	Method
Determine Acceptable Adverse Events That Are Related to Treatment	12 months

Secondary Outcome Measures

Name	Time	Method
Overall Response and Complete Remission Rate	12 months
Minimum Residual Disease (MRD)	12 months

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Cleveland, Ohio, United States