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

Technische Universität Dresden400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Leukemia, Nonlymphoblastic, Acute

Interventions

Cytarabine DosageDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Department I, University Hospital Carl Gustav Carus

Dresden, Germany

Outcomes

Primary Outcomes

- rate of complete remission

- overall survival

- relapse-free survival

Secondary Outcomes

- frequencies and grade of treatment side effects

- deaths within induction therapy

- deaths within postremission therapy

- feasibility according to dosages and time-intervals

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.