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A Two Stage Phase Ib Study to Investigate the Pharmocokinetics and Tolerability of Rituximab Subcutaneous Formulation in Patients With Follicular Lymphoma as Part of Maintenance Treatement

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Trial Profile

A Two Stage Phase Ib Study to Investigate the Pharmocokinetics and Tolerability of Rituximab Subcutaneous Formulation in Patients With Follicular Lymphoma as Part of Maintenance Treatement

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Nov 2021

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At a glance

  • Drugs Rituximab (Primary) ; Rituximab (Primary)
  • Indications Follicular lymphoma
  • Focus Pharmacokinetics; Registrational
  • Acronyms SparkThera
  • Sponsors Roche

Most Recent Events

  • 29 Mar 2017 According to a Halozyme Therapeutics media release, an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration has provided unanimous recommendation for subcutaneous rituximab coformulated with Halozyme Enhanze Technology. The FDA action date is June 26, 2017. Data from this study supported the application.
  • 13 Dec 2016 According to a Roche media release, health canada has approved the subcutaneous formulation of RITUXAN (rituximab) in combination with chemotherapy agents for the treatment of patients with low-grade CD20 antigen positive B-cell non-Hodgkin's lymphoma.
  • 12 May 2014 Final results published in the Journal of Clinical Oncology.

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