Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)

NCT00266136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2012-10-26

No results posted yet for this study

Summary

The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.

Conditions

Interventions

DRUG

Cytarabine

see protocol

DRUG

Thioguanine

see protocol

DRUG

Daunorubicin

see protocol

DRUG

Cyclophosphamide

see protocol

DRUG

G-CSF

see protocol

PROCEDURE

Autologous stem cell transplantation

for details see protocol

PROCEDURE

Allogeneic stem cell transplantation

for details see protocol

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER
  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV
  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Thomas Buechner, MD PhD · University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2007-01-31
Completion
2012-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00266136 on ClinicalTrials.gov