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Trial record 1 of 1 for:    NCT02793583
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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 : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE June 8, 2016
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE May 25, 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02793583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
Intervention  ICMJE
  • Drug: TGR-1202 + Ublituximab
  • Drug: TGR-1202
    Other Name: Umbralisib
  • Drug: TGR-1202 + Ublituximab + Bendamustine
    Other Name: Treanda
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
900
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2016)
200
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, Follicular, Mantle Cell Lymphoma 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TG Therapeutics Clinical Support Team 212-554-4279 clinicalsupport@tgtxinc.com
Listed Location Countries  ICMJE Australia,   Israel,   Italy,   Korea, Republic of,   Poland,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02793583
Other Study ID Numbers  ICMJE UTX-TGR-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be shared once the last patient visit has been completed
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Owen A O'Connor, MD, PhD Columbia University
PRS Account TG Therapeutics, Inc.
Verification Date November 2019

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