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Closed (no longer recruiting)Last updated: 30 January 2024

UTX-TGR-205: This phase II/III trial is evaluating the safety and effectiveness of a new oral drug (TGR-1202) in combination with a type of immunotherapy (ublituximab) with or without chemotherapy (bendamustine) in patients with recurrent or refractory Non-Hodgkin's LymphomaA 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

Clinical summary

Summary

Participants in this trial will be randomised into one of three treating arms; receiving either an oral dose of TGR-1202 alone, in combination with intravenous ublituximab or in combination with ublituximab and intravenous bendamustine.

Conditions

This trial is treating patients with Non-Hodgkin's Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

UTX-TGR-205

More information

Trial Identifiers

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Trial sponsor

TG Therapeutics, Inc.

Scientific 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

Eligibility

Inclusion

  • Diagnosis of Non-Hodgkin's Lymphoma including 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
  • MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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