Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation
NCT ID: NCT01015196
Last Updated: 2009-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
832 participants
INTERVENTIONAL
2001-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Idarubicine
Zavedos
Daunorubicine
Cerubidine
Interventions
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Zavedos
Cerubidine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
60 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, , France
Countries
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References
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Bertoli S, Bories P, Bene MC, Daliphard S, Lioure B, Pigneux A, Vey N, Delaunay J, Leymarie V, Luquet I, Blanchet O, Cornillet-Lefebvre P, Hunault M, Bouscary D, Fegueux N, Guardiola P, Dreyfus F, Harousseau JL, Cahn JY, Ifrah N, Recher C; Groupe Ouest-Est d'Etude des Leucemies Aigues et Autres Maladies du Sang (GOELAMS). Prognostic impact of day 15 blast clearance in risk-adapted remission induction chemotherapy for younger patients with acute myeloid leukemia: long-term results of the multicenter prospective LAM-2001 trial by the GOELAMS study group. Haematologica. 2014 Jan;99(1):46-53. doi: 10.3324/haematol.2013.091819. Epub 2013 Aug 23.
Guieze R, Cornillet-Lefebvre P, Lioure B, Blanchet O, Pigneux A, Recher C, Bonmati C, Fegueux N, Bulabois CE, Bouscary D, Vey N, Delain M, Turlure P, Himberlin C, Harousseau JL, Dreyfus F, Bene MC, Ifrah N, Chevallier P; GOELAMS. Role of autologous hematopoietic stem cell transplantation according to the NPM1/FLT3-ITD molecular status for cytogenetically normal AML patients: a GOELAMS study. Am J Hematol. 2012 Dec;87(12):1052-6. doi: 10.1002/ajh.23311. Epub 2012 Aug 22.
Lioure B, Bene MC, Pigneux A, Huynh A, Chevallier P, Fegueux N, Blaise D, Witz B, Delain M, Cornillon J, Luquet I, Blanchet O, Cornillet-Lefebvre P, Carre M, Hunault M, Larosa F, Lamy T, Randriamalala E, Ojeda-Uribe M, Berthou C, Fornecker L, Harousseau JL, Bouscary D, Ifrah N, Cahn JY; GOELAMS. Early matched sibling hematopoietic cell transplantation for adult AML in first remission using an age-adapted strategy: long-term results of a prospective GOELAMS study. Blood. 2012 Mar 22;119(12):2943-8. doi: 10.1182/blood-2011-05-352989. Epub 2012 Feb 9.
Other Identifiers
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BRD 99/10-L
Identifier Type: -
Identifier Source: org_study_id