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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Zavedos; Drug: Cerubidine

• Registration Number: NCT01015196
• Lead Sponsor: Nantes University Hospital

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

Not available

Study Timeline

• Study Start: 2001-01
• Status Verified: 2009-11
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Last Update Submitted: 2009-11-17
• Study First Posted: 2009-11-18
• Last Update Posted: 2009-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 832

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Idarubicine	Zavedos	-
Daunorubicine	Cerubidine	-

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France