Know Cancer

or
forgot password

AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.


Phase 4
16 Years
N/A
Not Enrolling
Both
Leukemia, Nonlymphoblastic, Acute

Thank you

Trial Information

AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.


The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy
including related and unrelated allogeneic stem cell transplantation for high risk AML
patients and related allogeneic and autologous stem cell transplantation for standard risk
AML patients in a multi-center setting. Furthermore it randomizes patients between
intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.


Inclusion Criteria:



- de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7

- de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T

- written informed consent

Exclusion Criteria:

- severe comorbidities

- severe uncontrolled complications of the leukemia

- previous therapy of leukemia/MDS

- HIV-Infection

- known relevant allergy against study medication

- pregnancy

- missing written informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

- rate of complete remission

Principal Investigator

Gerhard Ehninger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Carl Gustav Carus Dresden

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MK1-191

NCT ID:

NCT00180115

Start Date:

February 1996

Completion Date:

November 2008

Related Keywords:

  • Leukemia, Nonlymphoblastic, Acute
  • acute myeloid leukemia
  • cytarabine postremission dosage
  • risk adapted treatment strategy
  • allogeneic stem cell transplantation
  • autologous stem cell transplantation
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location