Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia
Nøgleord
Abstrakt
Beskrivelse
Will not be included in CR1 nor the patients with good forecast under chemotherapy, (Inv 16; t(8;21)), nor patients at the very high risk of relapse (anomalies complex cytogenetics). The conditioning of MA graft will be Cyclophosphamide and ICT with strong amounts. NMA graft will be made according to the protocol Seattle (fludarabine 30 mg/m2/j X 3 and ICT of 2 Gy). The study will be undertaken in 12 French centers of allograft taking part in the protocols ESPARTO or EORTC.
Datoer
| Sidst bekræftet: | 05/31/2005 |
| Først indsendt: | 09/15/2005 |
| Anslået tilmelding indsendt: | 09/15/2005 |
| Først indsendt: | 09/22/2005 |
| Sidste opdatering indsendt: | 12/12/2005 |
| Sidste opdatering indsendt: | 12/13/2005 |
| Faktisk startdato for undersøgelsen: | 06/30/2005 |
| Anslået afslutningsdato for undersøgelsen: | 06/30/2009 |
Tilstand eller sygdom
Intervention / behandling
Procedure: Allogenic transplantation
Fase
Kriterier for støtteberettigelse
| Alder berettiget til undersøgelse | 35 Years Til 35 Years |
| Køn, der er berettiget til undersøgelse | All |
| Accepterer sunde frivillige | Ja |
| Kriterier | 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 Exclusion Criteria: 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. |
Resultat
Primære resultatforanstaltninger
1. To show that NMA graft reduces mortality related to the procedure to 10%, compared to 30% waited in the arm of reference (α : 5%; p: 80%; bilateral formulation), 50 patients will be included in each arm [undefined]
Sekundære resultatforanstaltninger
1. 1- global survival, without relapse, and the various complications of the graft at 2 years 2- quality of life 3- the cost. 4- kinetics of the chimerism donor/receiver and his predictive value of the relapse and the reaction of the graft against the host. [undefined]
