This trial is terminated!
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Your journey
1What's a trial
2Find
3Review
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More info
You can access this
clinical trial
if you have
Indolent Non-Hodgkin's Lymphomas
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Provided treatments

  • Drug: Placebo
  • Drug: Rituximab
  • Drug: Idelalisib
Tris trial is registered with FDA with number: NCT01732913. The sponsor of the trial is Gilead Sciences and it is looking for 295 volunteers for the current phase.
Official trial title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas