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Trial record 1 of 1 for:    UNITY-CLL
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Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia (UNITY-CLL)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02612311
Recruitment Status : Active, not recruiting
First Posted : November 23, 2015
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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Brief Summary:
This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Biological: Obinutuzumab Biological: Ublituximab Drug: TGR-1202 Drug: Chlorambucil Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : November 19, 2015
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : January 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ublituximab + TGR-1202
  • Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions
  • TGR-1202: Fixed oral daily dose
 Biological: Ublituximab
Ublituximab: IV infusion

Drug: TGR-1202
TGR-1202: Oral daily dose
Active Comparator: Obinutuzumab + Chlorambucil
  • Obinutuzumab: IV infusion dose on Days 1, 8 and 15 in Cycle 1 followed by Day 1 infusion in Cycles 2 - 6
  • Chlorambucil: Oral dose on Days 1 and 15 of Cycles 1 - 6
 Biological: Obinutuzumab
Obinutuzumab: IV infusion
Other Name: GAZYVA

Drug: Chlorambucil
Chlorambucil: Oral dose
Other Name: Leukeran
Experimental: Ublituximab
- Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions
 Biological: Ublituximab
Ublituximab: IV infusion
Experimental: TGR-1202
- TGR-1202: Fixed oral daily dose
 Drug: TGR-1202
TGR-1202: Oral daily dose


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 3 years ]
    To assess the progression-free survival (PFS) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with TGR-1202 compared to obinutuzumab + chlorambucil


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Every 12 weeks up to 2 years ]
    To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202 compared to ublituximab and TGR-1202 alone


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:

  • Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
  • Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
  • Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor
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): NCT02612311


Locations
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Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02612311    
Other Study ID Numbers: UTX-TGR-304
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Leukemia, B-Cell
Obinutuzumab
Chlorambucil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action