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

  • STATUS
    Recruiting
  • End date
    Jul 22, 2022
  • participants needed
    900
  • sponsor
    TG Therapeutics, Inc.
Updated on 11 November 2020
Investigator
TG Therapeutics Clinical Support Team
Primary Contact
TG Therapeutics Investigational Trial Site (7.6 mi away) Contact
+200 other location
stem cell transplantation
lymphoma
hodgkin's disease
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
marginal zone lymphoma
large b-cell lymphoma
bendamustine

Summary

Unity NHL - 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

Details
Treatment TGR-1202, TGR-1202 + Ublituximab, TGR-1202 + Ublituximab + Bendamustine
Clinical Study IdentifierNCT02793583
SponsorTG Therapeutics, Inc.
Last Modified on11 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Lymphocytic Leukemia, Chronic or MALT Lymphoma or Lymphoma or Mantle cell lymphoma or Marginal Zone Lymphoma or Diffus...?
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
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