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Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm. Efficacy of Allogeneic Stem Cell Transplantation in Comparison to a Second Consolidation Chemotherapy in Elderly Patients With Newly Diagnosed AML in the Age Over 60 Years


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Acute Myeloid Leukaemia

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Trial Information

Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm. Efficacy of Allogeneic Stem Cell Transplantation in Comparison to a Second Consolidation Chemotherapy in Elderly Patients With Newly Diagnosed AML in the Age Over 60 Years


Inclusion Criteria:



- Patients of both sexes with age > 60 years and newly diagnosed acute myeloid
leukaemia as defined by new WHO classification

- written informed consent

Exclusion Criteria:

- pretreatment of leukemia

- no informed consent

- simultaneous inclusion in other studies

- mental disability

- contraindication for intensive chemotherapy

- AML FAB M3

- contraindication for allogeneic stem cell transplantation

- restriction of following organ functions:

- creatinine-clearance < 50 ml/min

- cardiac ejection fraction < 40 %

- severe pulmonary restriction

- bilirubin > 2x ULN; SGOT and SGPT > 4x ULN

- uncontrolled hypertension

- severe uncontrolled metabolism disturbance

- Karnofsky-performance-score < 70%

- hepatitis C

- other malignancy

- age of unrelated donor >70 years and age of related donor >75 years

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

comparison of event free survival (OSHO arm versus Standard intergroup arm)

Outcome Time Frame:

after 5 years

Safety Issue:

Yes

Principal Investigator

Dietger Niederwieser, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Leipzig, Germany

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

OSHO#069

NCT ID:

NCT01497002

Start Date:

April 2005

Completion Date:

December 2013

Related Keywords:

  • Acute Myeloid Leukaemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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