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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180115
First received: September 12, 2005
Last updated: July 16, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Leukemia, Nonlymphoblastic, Acute
Drug: Cytarabine Dosage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • - rate of complete remission
  • - overall survival
  • - relapse-free survival

Secondary Outcome Measures:
  • - frequencies and grade of treatment side effects
  • - deaths within induction therapy
  • - deaths within postremission therapy
  • - feasibility according to dosages and time-intervals

Estimated Enrollment: 400
Study Start Date: February 1996
Estimated Study Completion Date: November 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180115

Locations
Germany
Medical Department I, University Hospital Carl Gustav Carus
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden
  More Information

No publications provided by Technische Universität Dresden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00180115     History of Changes
Other Study ID Numbers: MK1-191
Study First Received: September 12, 2005
Last Updated: July 16, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
acute myeloid leukemia
cytarabine postremission dosage
risk adapted treatment strategy
allogeneic stem cell transplantation
autologous stem cell transplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014