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Protocol No. UW17086

Principal Investigator Chang, Julie

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ubilituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Objective Patients with Non-Hodgkin Lymphoma including Diffuse Large B-Cell Lymphoma this study is being done to see how effective the combination of investigational drugs: ublituximab and umbralisib (also referred to as TGR-1202), are when given together compared to when TGR-1202 is given alone.
After that part of the study is complete, investigators will want to see how effective the combination of investigational drug ublituximab and TGR-1202 is when given together compared to when the combination of ublituximab and TGR-1202 is when given with bendamustine.
For Follicular Lymphoma or Small Lymphocytic Lymphoma, there are three stages to the study. This first stage is being done to see how effective TGR-1202 is when given alone. Once that stage of the study is complete, the second stage is being done to see how effective the combination of investigational drugs, ublituximab and TGR-1202 are when given together, compared to when TGR-1202 is given alone. Once the second stage of the study is complete, the third stage of the study is being done to see how effective the combination of investigational drugs ublituximab and TGR-1202 is when given together compared to when the combination of ublituximab and TGR-1202 is given with bendamustine
Patients with Marginal Zone Lymphoma, this study will see how effective TGR-1202 is when given alone

Treatment Patients will receive either Ublituximab in combination with TGR-1202 and Bendamustine OR Ublituximab in combination with TGR-1202 OR TGR-1202 alone.

Description A Phase 2b Randomized Study looking at Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-HodgkinÂ’s Lymphoma

Key Eligibility
  • Histologically confirmed diagnosis of: B-cell NHL with histological subtype limited to the following: Follicular Lymphoma (FL) of Grade 1, 2, or 3a; Small Lymphocytic Lymphoma (SLL); Marginal Zone Lymphoma (MZL) (splenic, nodal, or extranodal); or Diffuse Large B-Cell Lymphoma (including High-grade B-cell lymphoma
  • FL/SLL patients: relapsed or refractory after ≥ 2 prior lines of therapy. Patients must have received an anti-CD20 mAb and an alkylating agent;
  • MZL patients: prior treatment with one or more lines of therapy including at least one CD20- directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after the most recent systemic treatment regimen;
  • DLBCL patients: relapsed or refractory to any prior standard therapy AND who are noncandidates for high-dose therapy or autologous stem cell transplant
  • Measurable disease, adequate organ system function, ECOG performance status ≤ 2, Male or female ≥ 18 years of age
  • Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study
  • No prior autologous hematologic stem cell transplant within 6 months
  • No prior allogeneic hematologic stem cell transplant
  • No known history of central nervous system lymphoma
  • No known histological transformation from chronic lymphocytic leukemia to large cell lymphoma
  • No prior exposure to idelalisib (CAL-101), duvelisib (IPI-145), or any drug that specifically inhibits phosphoinositide-3-kinase (PI3K)
  • No prior or current secondary malignancy within 3 years
  • No severe cardiac history

  • Applicable Disease Sites Lymphoma

    Status Open

    Participating Institutions UW Hospital and Clinics