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Spots Global Cancer Trial Database for Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation

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Trial Identification

Brief Title: Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation

Official Title: 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

Study ID: NCT01015196

Interventions

Zavedos
Cerubidine

Study Description

Brief Summary: First randomization: After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before ASCT) Second randomization: After achieving 1st CR: all patients received non intensive consolidation course Familial HLA typing required for all patients Patients with HLA-identical sibling: Patients with very good prognostic factors (CBF leukemias, WBC \< 30 giga/l at diagnosis, 1st CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR; received 2 more courses of intensive consolidation chemotherapy All others patients received an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative conditioning regimen For patients aged over 51 and less than 61= arm m: intensive chemotherapy consolidation course.

Detailed Description:

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Nantes University Hospital, Nantes, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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