A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects with Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

Trial Profile

A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects with Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2017

At a glance

  • Drugs Ibrutinib (Primary) ; Temsirolimus
  • Indications Mantle-cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms NAP; RAY
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 19 Jun 2017 Long term data from this trial were published in a Janssen-Cilag Media Release.
    • 19 Jun 2017 According to a Janssen-Cilag media release, long-term data from this trial presented at the 14th International Conference on Malignant Lymphoma (ICML).
    • 06 Dec 2016 Results (n=1509) of pooled analysis assessing risks of Afib/Aflutter and all-grade bleeding events associated with ibrutinib treatment using data from this and other three trials (NCT01578707, NCT01611090, NCT01722487) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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