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Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03379051
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : October 14, 2020
James P. Wilmot Cancer Center
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
Phase I/II Study of Venetoclax in Combination with Ublituximab and Umbralisib (TGR-1202) in Subjects with Relapsed or Refractory CLL/SLL, Richter's Transformation and Mantle Cell Lymphoma

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Richter Syndrome Mantle Cell Lymphoma Drug: Venetoclax Drug: Umbralisib Drug: Ublituximab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Ublituximab + Umbralisib + 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
Drug: Venetoclax
BCL-2 Inhibitor
Other Name: Venclexta

Drug: Umbralisib
PI3K-Delta Inhibitor
Other Name: TGR-1202

Drug: Ublituximab
Glycoengineered Anti-CD20 mAb
Other Name: TG-1101

Primary Outcome Measures :
  1. Determine Acceptable Adverse Events That Are Related to Treatment [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Complete Remission Rate [ Time Frame: 12 months ]
  2. Minimum Residual Disease (MRD) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03379051

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Contact: TG Therapeutics Clinical Support Team 212-554-4484

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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Shuo Ma, MD, PhD         
United States, New York
Wilmot Cancer Institute - University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Paul Barr, MD         
United States, Ohio
Cleveland Clinic- Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Brian Hill, MD, PhD         
Sponsors and Collaborators
TG Therapeutics, Inc.
James P. Wilmot Cancer Center
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Study Chair: Paul Barr, MD Wilmot Cancer Institute - University of Rochester
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Responsible Party: TG Therapeutics, Inc. Identifier: NCT03379051    
Other Study ID Numbers: U2-VEN-109
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents