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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180115
First Posted: September 16, 2005
Last Update Posted: July 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: July 17, 2007
Last Verified: July 2007

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
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs