drugset / Trial / NCT00199147

Efficacy of G-CSF-Priming in Elderly AML Patients

NCT00199147

Phase 4 Unknown 250 enrolled Johann Wolfgang Goethe University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.

Timeline

Start
2000-01
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject G-CSF Unknown
Background Cytarabine Small molecule
Background Etoposide Small molecule
Background Fludarabine Small molecule
Background Idarubicin Small molecule