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Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result


Phase 3
16 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result


Inclusion Criteria:



- Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced
AML after healed primary malignom; or refractory anemia with excess of blasts in
transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical
and with immunological phenotyping

- Cytogenetical tests must be performed for each patient

- Age: 16 - 60 years

- All patients have to be informed about the character of the study. Written informed
consent of each patient at study entry.

Exclusion Criteria:

- Organic insufficiency: Insufficiency of the kidneys (Crea > 1.5 x upper normal serum
level), or insufficiency of the liver (bilirubin, SGOT or AP > 2 x upper normal serum
level) uncaused by the AML; severe obstruction or restrictive ventilation disorder,
heart failure with a ejection fraction < 0.5

- Secondary malignom

- Other severe diseases

- Pregnancy

- Participation in an concurrent clinical study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

relapse-free survival

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Hartmut Döhner, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine III, University of Ulm

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AMLHD98A

NCT ID:

NCT00146120

Start Date:

May 1998

Completion Date:

May 2005

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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