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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2022

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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

  • 01 Oct 2022 Results assessing risk conferred by known biological factors, including increased MYC expression, blastoid morphology, aberrations of TP53, and truncated CCND1 3' untranslated region published in the Leukemia
  • 21 Jun 2020 Results evaluating the the prognostic capability of the MCL35 assay presented at the 25th Congress of the European Haematology Association.
  • 07 Dec 2019 Results of a 7.5 year pooled analysis (n=370) of patients with relapsed/refractory Mantle-cell-lymphoma from three trials (SPARK, RAY and PCYC-1104) were presented at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #1538).

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