Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06235398
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-23
Brief Title:
Upfront Related Donor Transplantation in Patients With Myelodisplatic Syndrome a Phase 2 Trial
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Upfront Related Donor Transplantation in Patients With Myelodisplatic Syndrome a Phase 2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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:
FIRST ALLO MDS
Brief Summary:
Three recent prospective transplantno transplant studies concluded to an advantage of OS with transplantation in patients with high or intermediate-2 IPSS risk not significant in Krögers study No prospective randomized trial has assessed the pre-transplant therapy in MDS patients yet but some information can be extracted from these 3 recent studies In the French study n162 72 patients with a donor received HSCT previously treated by hypomethylating agent HMA in 71 of them There was a trend to a better survival in patients achieving a complete remission with pre-graft therapy HR 055 p0088 and higher risk of death in unresponsiveness patients transformed into AML HR 236 p0008 In Nakamuras study n384 83 of patients with a donor were transplanted previously treated by HMA in 682 The multivariable Cox model for Overall Survival OS and Leukemia-free survival showed an excess risk in patients treated by HMA Moreover responders still have a higher risk of mortality as compared to patients who did not receive any pre-graft therapy HR 2417 p00054 In the German study the aim was to initiate azacytidine at inclusion and to transplant patients after 4 cycles if a donor was identified1 Among 170 registered patients 162 initiated 5-aza but 36 of them were lost during this pre-graft therapy before allocation to donor or no-donor arm for different reasons including death n12 After 4 cycles of 5-aza 7981 patients donor arm were transplanted The multivariable analysis showed remission status did not influence OS Those 3 previous clinical trials thus suggest that a substantial number of patients planned for transplantation are not transplanted nowadays while no evidence of HMA benefit before HSCT has been clearly identified This phase 2 study aim to assess the feasibility of upfront HSCT in patients with high risk MDS in order to increase the probability to be transplanted and to achieve a subsequent remission and better survival
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None