NCT00199147

Efficacy of G-CSF-Priming in Elderly AML Patients

Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (planned)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine
DRUG	Etoposide
DRUG	Idarubicin
DRUG	G-CSF
DRUG	Fludarabine
PROCEDURE	Stem cell apheresis
PROCEDURE	Stem cell transplantation

Timeline

• Start date: 2000-01-01
• First posted: 2005-09-20
• Last updated: 2005-10-26

Locations

1 site across 1 country: Germany