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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199147

Enrollment

250

Registered

2005-09-20

Start date

2000-01-31

Completion date

Unknown

Last updated

2005-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief 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.

Interventions

DRUGCytarabine

DRUGEtoposide

DRUGIdarubicin

DRUGG-CSF

DRUGFludarabine

PROCEDUREStem cell apheresis

PROCEDUREStem cell transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

61 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or * Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or after preceeding MDS or * Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or * Extramedullary AML (chloroma, granulocytic sarcoma) * Age greater than 60 years (not including 60 years) * ECOG performance status 0, 1, or 2 * Written informed consent

Exclusion criteria

* Patients with a t(15;17) translocation * Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV) * Patients with severe complications of the leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock. * Severe pulmonary disease (diffusion capacity for CO2 of less than 50%) * Significant renal dysfunction (creatinine clearance \< 60/min/min) * Bilirubin \> 2mg% (\>34.2 mmol/l) * Patients with a clinically active second malignancy * Patients with a psychiatric, addictive, or any disorder wich compromises ability to give truly informed consent for participating in this study * HIV positivity * Known refractoriness to platelet transfusion, inability to adequately substitute blood products

Design outcomes

Primary

Measure	Time frame
-Overall survival	—
-Remission rate after induction therapy	—
-Remission duration	—
-Disease free survival	—

Secondary

Measure	Time frame
-Toxicity according to WHO	—
-Death in induction therapy	—
-Feasibility to mobilize peripheral blood stem cells	—
-Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026