AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients
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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. |
- - rate of complete remission
- - overall survival
- - relapse-free survival
- - 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 |
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 |
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| Germany | |
| Medical Department I, University Hospital Carl Gustav Carus | |
| Dresden, Germany, 01307 | |
| Principal Investigator: | Gerhard Ehninger, MD | University Hospital Carl Gustav Carus Dresden |
More Information
No publications provided by Dresden University of Technology
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 Dresden University of Technology:
|
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 May 23, 2013