Clinical trial NCT00199147: Efficacy of G-CSF-Priming in Elderly AML Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 250
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: -Remission rate after induction therapy
measure: -Remission duration
measure: -Disease free survival
measure: -Overall survival
Secondary outcomes:
measure: -Toxicity according to WHO
measure: -Death in induction therapy
measure: -Feasibility to mobilize peripheral blood stem cells
measure: -Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Medical Department II
Study officials:
affiliation: University Hospital, Medical Department II, Frankfurt, Germany
name: Oliver G Ottmann, MD
role: STUDY_CHAIR
References: