- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379051
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
August 19, 2022 updated by: TG Therapeutics, Inc.
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- TG Therapeutics Investigational Trial Site
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-
New York
-
Rochester, New York, United States, 14642
- TG Therapeutics Investigational Trial Site
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Ohio
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Cleveland, Ohio, United States, 44195
- TG Therapeutics Investigational Trial Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
BCL-2 Inhibitor
Other Names:
PI3K-Delta Inhibitor
Other Names:
Glycoengineered Anti-CD20 mAb
Other Names:
|
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
|
PI3K-Delta Inhibitor
Other Names:
Glycoengineered Anti-CD20 mAb
Other Names:
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine Acceptable Adverse Events That Are Related to Treatment
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Response and Complete Remission Rate
Time Frame: 12 months
|
12 months
|
Minimum Residual Disease (MRD)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Paul Barr, MD, Wilmot Cancer Institute - University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2018
Primary Completion (Actual)
May 26, 2022
Study Completion (Actual)
June 16, 2022
Study Registration Dates
First Submitted
December 14, 2017
First Submitted That Met QC Criteria
December 14, 2017
First Posted (Actual)
December 20, 2017
Study Record Updates
Last Update Posted (Actual)
August 22, 2022
Last Update Submitted That Met QC Criteria
August 19, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Leukemia, Lymphocytic, Chronic, B-Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Venetoclax
Other Study ID Numbers
- U2-VEN-109
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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