drugset / Trial / NCT01611116

Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia

NCT01611116

Phase 2 Completed 33 enrolled Goethe University
RandomizedParallel-groupTriple-blindTreatment

Summary

Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a consequence, refractory disease and relapse frequently occur in AML, especially in elderly patients. The investigators propose that the addition of temsirolimus may improve standard AML chemotherapy. Furthermore, temsirolimus may specifically target the leukemia-initiating cells in AML, thereby reducing the risk of leukemia relapse. The study's main part is preceded by a open label run-in part, in which optimal temsirolimus dose and schedule for the main part o the study will be determined.

Timeline

Start
2012-05
Primary completion
2017-04-26
Completion
2017-04-26

Publications

  • Results Posting of Results in EUDRACT Database: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-002365-37/results

Drugs

EvaluationDrugModalityDoseRoute
Subject Temsirolimus Small molecule Intravenous