NCT01611116

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

A Double-blind, Placebo-controlled, Randomized, Multicenter Phase II Trial to Assess the Efficacy of Temsirolimus Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloblastic Leukemia

Interventions

Type	Name	Description
DRUG	sodium chloride solution 0.9%	intravenous application added to standard chemotherapy on up to 8 predefined days during the course of study treatment
DRUG	temsirolimus	intravenous application added to standard chemotherapy on up to 16 predefined days during the course of study treatment

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-04-26
• Completion: 2017-04-26
• First posted: 2012-06-04
• Last updated: 2023-05-24

Locations

5 sites across 1 country: Germany