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Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma (UNITY-NHL)

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ClinicalTrials.gov Identifier: NCT02793583
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab with or without bendamustine and TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or that has not responded to standard treatment.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma Mantle Cell Lymphoma Drug: TGR-1202 + Ublituximab Drug: TGR-1202 Drug: TGR-1202 + Ublituximab + Bendamustine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: TGR-1202 + Ublituximab
TGR-1202 oral daily dose in combination with Ublituximab intravenous administration
Drug: TGR-1202 + Ublituximab
Experimental: TGR-1202
TGR-1202 oral daily dose
Drug: TGR-1202
Experimental: TGR-1202 + Ublituximab + Bendamustine
TGR-1202 oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Drug: TGR-1202 + Ublituximab + Bendamustine
Other Name: Treanda




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]


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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:

  • Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma
  • Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
  • 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 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor

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): NCT02793583


Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4279 clinicalsupport@tgtxinc.com

  Show 138 Study Locations
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Owen A O'Connor, MD, PhD Columbia University

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02793583     History of Changes
Other Study ID Numbers: UTX-TGR-205
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared once the last patient visit has been completed

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents