Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224614
Status:
UNKNOWN
Last Update Posted:
2005-12-14
First Post:
2005-09-16
Brief Title:
Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Will not be included in CR1 nor the patients with good forecast under chemotherapy Inv 16 t821 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 mgm2j 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOM04088 | None | None | None |