Efficacy of G-CSF-Priming in Elderly AML Patients

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00199147
• Other study ID #: AML-elderly 01/99 Trial
• Status: Recruiting
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: October 25, 2005
• Start date: January 2000

Study information

• Verified date: September 2005
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 61 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cytarabine

• Etoposide

• Idarubicin

• G-CSF

• Fludarabine

Procedure:
• Stem cell apheresis

• Stem cell transplantation

Locations

Country	Name	City	State
Germany	University Hospital, Medical Department II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-Remission rate after induction therapy
Primary	-Remission duration
Primary	-Disease free survival
Primary	-Overall survival
Secondary	-Toxicity according to WHO
Secondary	-Death in induction therapy
Secondary	-Feasibility to mobilize peripheral blood stem cells
Secondary	-Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients