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

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ClinicalTrials.gov Identifier: NCT03379051
Recruitment Status : Terminated (Strategic/Business Decision)
First Posted : December 20, 2017
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
James P. Wilmot Cancer Center
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma Drug: Venetoclax Drug: Umbralisib Biological: Ublituximab Drug: Lenalidomide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : May 26, 2022
Actual Study Completion Date : June 16, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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

Biological: Ublituximab
Glycoengineered Anti-CD20 mAb
Other Name: TG-1101
Experimental: Ublituximab + Umbralisib + 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
 Drug: Umbralisib
PI3K-Delta Inhibitor
Other Name: TGR-1202

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

Drug: Lenalidomide
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
Other Name: Revlimid


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

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

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

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)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03379051


Locations
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United States, Illinois
TG Therapeutics Investigational Trial Site
Chicago, Illinois, United States, 60611
United States, New York
TG Therapeutics Investigational Trial Site
Rochester, New York, United States, 14642
United States, Ohio
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
TG Therapeutics, Inc.
James P. Wilmot Cancer Center
Investigators
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Study Chair: Paul Barr, MD Wilmot Cancer Institute - University of Rochester
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03379051    
Other Study ID Numbers: U2-VEN-109
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

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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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
 Lenalidomide
Venetoclax
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents