Informations générales (source: ClinicalTrials.gov)
Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2005
juillet 2009
29 juin 2024
The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by
cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is
recognized acute myeloid leukaemia (AML) of the adult for the patients of less than 55
years, because it offers chances of cure higher than chemotherapy or the auto-graft.
However, mortality related to the traditional graft is approximately 30% to 1 year. The
recent use of the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect
rests exclusively on the allogenic effect "graft-versus-leukaemia" makes it possible to
obtain among patients of more than 55 years in complete reemission (CR), survivals
without relapses comparable with the traditional allograft among patients of more than 35
years. The major interest of NMA graft is to reduce early mortality related to the graft.
This reduction should be all the more significant as the patient is younger, and thus
bring to a better survival. There is not, at the present hour, of prospective comparative
study of the two procedures of graft. Taking into account the results observed after NMA
graft among patients of more than 55 years, and taking into account the toxicity of the
standard graft between 35 and 55 years, it is essential to now compare the 2 approaches
among patients who do not have a counter-indication for one or the other, in the age
bracket where the toxicity of the traditional graft is highest.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL SAINT CAMILLE | CORDONNIER Catherine, professor | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Age: from 35 to 55 years completed
2. de novo Acute Myeloid Leukaemia (AML) in Complete remission (CR)1, requiring an
allograft according to the therapeutic protocol in which (or according to which) the
patient is treated or secondary AML with a myelodysplasy or a chemotherapy in CR1 or
de novo AML or secondary to a myelodysplasy or a chemotherapy, in CR2.
3. having an géno-identical fraternal donor
4. having received, since obtaining the remission (1 or 2) a consolidation comprising
at least 6 bolus of Aracytine (> 500 mg/m2 for each amount) and at least 1 day of
anthracycline to the usual amounts (Idarubicin: 12 mg/m2 or Daunorubicin 50 to 80
mg/m2)
5. Signed assent of receiver
6. Signed assent of the donor
1. Age: from 35 to 55 years completed
2. de novo Acute Myeloid Leukaemia (AML) in Complete remission (CR)1, requiring an
allograft according to the therapeutic protocol in which (or according to which) the
patient is treated or secondary AML with a myelodysplasy or a chemotherapy in CR1 or
de novo AML or secondary to a myelodysplasy or a chemotherapy, in CR2.
3. having an géno-identical fraternal donor
4. having received, since obtaining the remission (1 or 2) a consolidation comprising
at least 6 bolus of Aracytine (> 500 mg/m2 for each amount) and at least 1 day of
anthracycline to the usual amounts (Idarubicin: 12 mg/m2 or Daunorubicin 50 to 80
mg/m2)
5. Signed assent of receiver
6. Signed assent of the donor
1. If CR1: AML with T 8,21 or inv 16 or LAM3, or AML with complex anomalies
cytogenetics (= 5 anomalies without relation between them)
2. If CR2: duration of CR1 < 4 months
3. Acute transformation of a myeloproliferative syndrome
4. Former autograft or allogreffe
5. Karnofsky < 50%
6. Clearance of creatinin < 40 ml/min
7. Transaminases > 8 N
8. Any situation contra-indicating a traditional conditioning of allograft, in
particular: serious cardiopathy, chronic respiratory insufficiency cutting down the
pulmonary functions by at least 30%, fibrose hepatic.
9. Donor having a counter-indication with the administration of growth promoters or a
general anaesthesia.