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Efficacy of G-CSF-Priming in Elderly AML Patients

NCT00199147 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2005-10-26

No results posted yet for this study

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

Interventions

DRUG

Cytarabine

DRUG

Etoposide

DRUG

Idarubicin

DRUG

G-CSF

DRUG

Fludarabine

PROCEDURE

Stem cell apheresis

PROCEDURE

Stem cell transplantation

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Oliver G Ottmann, MD · University Hospital, Medical Department II, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00199147 on ClinicalTrials.gov