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

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180115

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 IV

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine Cytarabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Dresden University of Technology:

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

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

Dresden University of Technology

Investigators

Principal Investigator:

Gerhard Ehninger, MD

University Hospital Carl Gustav Carus Dresden

More Information

Study ID Numbers:	MK1-191
Study First Received:	September 12, 2005
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00180115
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

acute myeloid leukemia
cytarabine postremission dosage
risk adapted treatment strategy
allogeneic stem cell transplantation
autologous stem cell transplantation

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Acute myeloid leukemia, adult
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents

Physiological Effects of Drugs
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009