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 2TerminatedNCT03379051

TG Therapeutics, Inc.78 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

Interventions

VenetoclaxDRUG

BCL-2 Inhibitor

UmbralisibDRUG

PI3K-Delta Inhibitor

UblituximabBIOLOGICAL

Glycoengineered Anti-CD20 mAb

Lenalidomide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

TG Therapeutics Investigational Trial Site

Chicago, Illinois, United States

TG Therapeutics Investigational Trial Site

Rochester, New York, United States

TG Therapeutics Investigational Trial Site

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Determine Acceptable Adverse Events That Are Related to Treatment

Time frame: 12 months

Secondary Outcomes

Overall Response and Complete Remission Rate

Time frame: 12 months

Minimum Residual Disease (MRD)

Time frame: 12 months

Data from ClinicalTrials.gov

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