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A Pilot, Pharmacodynamic Correlate, Multi-Institutional Trial of Sirolimus in Combination With Chemotherapy (Mitoxantrone, Etoposide, Cytarabine) for the Treatment of High Risk, Acute Myelogenous Leukemia.

Trial Profile

A Pilot, Pharmacodynamic Correlate, Multi-Institutional Trial of Sirolimus in Combination With Chemotherapy (Mitoxantrone, Etoposide, Cytarabine) for the Treatment of High Risk, Acute Myelogenous Leukemia.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Sirolimus (Primary) ; Cytarabine; Etoposide; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Pharmacodynamics; Therapeutic Use

Most Recent Events

  • 02 Apr 2018 According to results of a combined analysis of the pilot (NCT00780104; n=15) and subsequent phase II (NCT01184898; n=36) study published in the Investigational New Drugs Journal, secondary endpoints for both studies included assessment of safety, overall survival and incidence of subsequent allogeneic transplantation.
  • 02 Apr 2018 Results of a combined analysis of the pilot (NCT00780104; n=15) and subsequent phase II (NCT01184898; n=36) study assessing the association between mTORC1 target inhibition in leukemic blasts and clinical response to a regimen combining sirolimus and MEC chemotherapy, published in the Investigational New Drugs Journal.
  • 19 Oct 2016 Status changed from active, no longer recruiting to completed.

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