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

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ClinicalTrials.gov Identifier: NCT03379051
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
James P. Wilmot Cancer Center
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
This study will be a standard 3+3 design with a lead in of umbralisib (TGR-1202) + ublituximab for 12 weeks, i.e. 3 cycles, followed by venetoclax (20 mg - 200 mg) along with umbralisib (TGR-1202) and ublituximab for patients with relapsed/refractory CLL.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Venetoclax Drug: Umbralisib Drug: Ublituximab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

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

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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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03379051


Contacts
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Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

Locations
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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
Investigators
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Study Chair: Paul Barr, MD Wilmot Cancer Institute - University of Rochester

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03379051     History of Changes
Other Study ID Numbers: U2-VEN-109
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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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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Venetoclax
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs