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Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma (UNITY-DLBCL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by TG Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02793583
First received: May 23, 2016
Last updated: February 12, 2017
Last verified: February 2017
  Purpose
This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab compared to TGR-1202 alone as a possible treatment for Diffuse Large B-cell Lymphoma (DLBCL) that has come back or that has not responded to standard treatment.

Condition Intervention Phase
Diffuse Large B-Cell Lymphoma
Drug: TGR-1202 + Ublituximab
Drug: TGR-1202
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

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

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

Estimated Enrollment: 200
Study Start Date: June 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Diffuse Large B-Cell 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 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02793583

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

  Show 42 Study Locations
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Owen A O'Connor, MD, PhD Columbia University
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02793583     History of Changes
Other Study ID Numbers: UTX-TGR-205 
Study First Received: May 23, 2016
Last Updated: February 12, 2017
Individual Participant Data  
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, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on February 24, 2017