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A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

Trial Profile

A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2021

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At a glance

  • Drugs Pixantrone (Primary) ; Rituximab (Primary) ; Gemcitabine
  • Indications Diffuse large B cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PIX-R
  • Sponsors Cell Therapeutics; CTI BioPharma

Most Recent Events

  • 13 Jun 2019 According to a Servier media release, the EC approval is based on data from the global clinical development of PIXUVRI which included pivotal study (PIX301) and a further Phase III clinical study (PIX306) conducted to satisfy requirements of the conditional authorization.
  • 13 Jun 2019 According to a Servier media release, the European Commission (EC) has approved the conversion of the conditional approval of PIXUVRI (pixantrone) into a standard marketing authorization as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.
  • 09 Apr 2019 According to a Servier media release, the positive opinion from the CHMP is based on data from the global clinical development of PIXUVRI which included pivotal study (PIX301) and a further Phase III clinical study (PIX306) conducted to satisfy requirements of the conditional authorization.

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