AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

Technische Universität Dresden

Status and phase: Completed; Phase 4

Conditions: Leukemia, Nonlymphoblastic, Acute

Treatments: Drug: Cytarabine Dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT00180115

MK1-191

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)