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AML 2001: a Phase III Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (ASCT) as Consolidation Strategy for Adults Aged 15 to 60 With Acute Myeloid Leukemia (AML) in First Complete Remission (CR).rémission complète d'Une Leucémie Aiguë Myéloblastique


Phase 2/Phase 3
15 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

AML 2001: a Phase III Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (ASCT) as Consolidation Strategy for Adults Aged 15 to 60 With Acute Myeloid Leukemia (AML) in First Complete Remission (CR).rémission complète d'Une Leucémie Aiguë Myéloblastique


Inclusion Criteria:



- Patients aged 15 to 60 years

- Diagnosis untreated AML (FAB 0 to 2, 4 to 7): more than 20% marrow blasts according
to WHO classification

- Signed informed consent required

Exclusion Criteria:

- AML3 subtype

- Previous diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative disease;
patients with previous chemotherapy or radiotherapy were eligible if they had no
previous diagnosis of MDS

- Isolated extramedullary disease

- Inadequate performance status (≥ 3), cardiac function (LVEF < 40%, severe arythmia or
unstable coronary disease), renal function (creatininine > 150 µmol/l), liver
functional tests (bilirubin > 35 µmol/l, liver enzymes > 4 times normal values); life
expectancy < 3 months

- Informed consent refusal

Type of Study:

Interventional

Study Design:

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

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 99/10-L

NCT ID:

NCT01015196

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • acute myeloid leukemia in first complete remission
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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