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A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias

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Trial Profile

A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Mar 2023

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At a glance

  • Drugs Sirolimus (Primary) ; Cytarabine; Etoposide; Mitoxantrone
  • Indications Myeloid leukaemia
  • Focus Pharmacodynamics
  • Acronyms UPCC 02407

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.
  • 29 Sep 2010 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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