Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL.

Trial Profile

Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Feb 2017

At a glance

  • Drugs Rituximab (Primary) ; Carmustine; Cisplatin; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Melphalan; Prednisone; Vincristine
  • Indications Mantle-cell lymphoma
  • Focus Therapeutic Use
  • Acronyms LYMA
  • Most Recent Events

    • 24 Jan 2017 CT.gov record reported trial status as completed with end date Aug 2012 (24 Oct 2012-archieve date) which was the enrollment end date and not the study end date. Later the archive (as of 15 Mar 2016) updated the study end date as Mar 2016.As the final results are now presented with 4 year EFS, I have now changed the status active, no longer recruiting to completed.Retained Mar 2016 as the study end date as per CT.gov record.
    • 06 Dec 2016 Status changed from active, no longer recruiting to completed, according to final results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
    • 06 Dec 2016 Primary endpoint (Event-free survival (EFS) post Rituximab maintenance therapy) has been met, according to results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
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