Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia; Richter Syndrome
• Interventions: Drug: Umbralisib; Biological: ublituximab; Biological: TG-1501

• Registration Number: NCT02535286
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Study Start: 2015-09-18
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
• 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 14 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TG-1501 + Ublituximab + Umbralisib	ublituximab	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
TG-1501 + Ublituximab + Umbralisib	TG-1501	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
TG-1501 + Ublituximab + Umbralisib	Umbralisib	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals

Primary Outcome Measures

Name	Time	Method
Determine Acceptable Adverse Events That Are Related to Treatment	6 months of therapy	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 1 year	The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Seattle, Washington, United States