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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 : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

May 23, 2016
June 8, 2016
October 9, 2018
June 2016
May 2019   (Final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]
Same as current
Complete list of historical versions of study NCT02793583 on ClinicalTrials.gov Archive Site
Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
    Other Name: Treanda
  • Experimental: TGR-1202 + Ublituximab
    TGR-1202 oral daily dose in combination with Ublituximab intravenous administration
    Intervention: Drug: TGR-1202 + Ublituximab
  • Experimental: TGR-1202
    TGR-1202 oral daily dose
    Intervention: Drug: TGR-1202
  • Experimental: TGR-1202 + Ublituximab + Bendamustine
    TGR-1202 oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
    Intervention: Drug: TGR-1202 + Ublituximab + Bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
200
July 2019
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: TG Therapeutics Clinical Support Team 212-554-4279 clinicalsupport@tgtxinc.com
Australia,   Israel,   Italy,   Korea, Republic of,   Poland,   Slovakia,   Spain,   United Kingdom,   United States
 
 
NCT02793583
UTX-TGR-205
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Data will be shared once the last patient visit has been completed
TG Therapeutics, Inc.
TG Therapeutics, Inc.
Not Provided
Study Chair: Owen A O'Connor, MD, PhD Columbia University
TG Therapeutics, Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP