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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


Phase 4
61 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

-Remission rate after induction therapy

Principal Investigator

Oliver G Ottmann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital, Medical Department II, Frankfurt, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AML-elderly 01/99 Trial

NCT ID:

NCT00199147

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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