Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
NCT ID: NCT03379051
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2018-03-27
2022-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Venetoclax
BCL-2 Inhibitor
Umbralisib
PI3K-Delta Inhibitor
Ublituximab
Glycoengineered Anti-CD20 mAb
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
Umbralisib
PI3K-Delta Inhibitor
Ublituximab
Glycoengineered Anti-CD20 mAb
Lenalidomide
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
Interventions
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Venetoclax
BCL-2 Inhibitor
Umbralisib
PI3K-Delta Inhibitor
Ublituximab
Glycoengineered Anti-CD20 mAb
Lenalidomide
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Known histological transformation from CLL to an aggressive lymphoma (Richter's)
18 Years
ALL
No
Sponsors
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James P. Wilmot Cancer Center
OTHER
TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Barr, MD
Role: STUDY_CHAIR
Wilmot Cancer Institute - University of Rochester
Locations
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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
Countries
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References
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Hill BT, Ma S, Zent CS, Baran AM, Wallace DS, Advani A, Winter A, Winter J, Gordan L, Karmali R, Liesveld JL, Mulford DA, Rowland C, Bui A, Sportelli P, Miskin HP, Weiss MS, Friedberg JW, Barr PM. Response-adapted, time-limited venetoclax, umbralisib, and ublituximab for relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2024 Jan 23;8(2):378-387. doi: 10.1182/bloodadvances.2023010693.
Other Identifiers
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U2-VEN-109
Identifier Type: -
Identifier Source: org_study_id
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