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Completed

NCT Number: NCT00180115

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

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.

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Key information

Conditions

Leukemia, Nonlymphoblastic, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Department I, University Hospital Carl Gustav Carus

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine Dosage

Drug

Primary outcomes

  1. - rate of complete remission

  2. - overall survival

  3. - relapse-free survival

Secondary outcomes

  1. - frequencies and grade of treatment side effects

  2. - deaths within induction therapy

  3. - deaths within postremission therapy

  4. - feasibility according to dosages and time-intervals

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.

Important dates

Study start
1996
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Jul 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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