Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06083129
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-10-09
Brief Title:
Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 1010 HLA Matched Unrelated Donor
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 1010 HLA Matched Unrelated Donor Following a Reduced Intensity Conditioning Regimen by Fludarabine-treosulfan
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
OPTISAGE
Brief Summary:
Allogeneic hematopoietic stem cell transplantation allo-HSCT remains the only curative therapy in acute myeloid leukemia AML and myelodysplastic syndrome MDS Most of the patients requiring an allo-HSCT are above 50 years of age and are transplanted with a reduced intensity conditioning RIC regimen The optimal RIC and Graft Versus Host Disease GVHD prophylaxis regimen allowing a good control of the disease while preventing GVHD remains to be determined for elderly patients A phase III trial comparing the conventional RIC fludarabine-busulfan 2 days to fludarabine-treosulfan demonstrated an advantage for the flu-treosulfan arm in terms of event free survival EFS that should therefore be considered as the new standard of RIC regimen for AML and MDS GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia GVL effect and immune reconstitution Anti-thymocyte globulins ATG are recommended to reduce the risk of acute and chronic GVHD in transplants performed with matched unrelated donors However the optimal type of ATG between the 2 approved brands ATG-thymoglobulin and ATLG-grafalon displaying distinct characteristics and the optimal dose of ATG are still unknown In a retrospective study of patients transplanted mainly with RIC with matched related and unrelated donors for haematological malignancies we observed that Anti-T lymphocyte globulin ATLG was associated with a reduction of grade II-IV acute GVHD in comparison to ATG without increasing the incidence of relapse
In this phase III randomised study we propose to compare GVHD prevention with ATG versus ATLG in AML and MDS patients above 50 years of age transplanted with a matched unrelated donor following a fludarabine-treosulfan RIC with the hypothesis that ATLG would better control GVHD in this population of patients thus limiting the risk of morbidity and mortality of the procedure
In this phase III randomised study we propose to compare GVHD prevention with ATG versus ATLG in AML and MDS patients above 50 years of age transplanted with a matched unrelated donor following a fludarabine-treosulfan RIC with the hypothesis that ATLG would better control GVHD in this population of patients thus limiting the risk of morbidity and mortality of the procedure
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