Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06083129
PHASE3

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 10/10 HLA Matched Unrelated Donor

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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, 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. This phase III randomised study 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.

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 10/10 HLA Matched Unrelated Donor Following a Reduced Intensity Conditioning Regimen by Fludarabine-treosulfan

Key Details

Gender

All

Age Range

50 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2023-11-28

Completion Date

2028-11-28

Last Updated

2026-04-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Grafalon

10 mg/Kg/day IV for 3 consecutive days (day-3 to -1 before transplantation)

DRUG

Thymoglobulin

2.5 mg/Kg/day IV for 2 consecutive days (day-3 and -2 before transplantation)

Locations (28)

CHU Amiens

Amiens, France

CHU Angers

Angers, France

CHU Besançon

Besançon, France

CHU Bordeaux

Bordeaux, France

CHU Brest

Brest, France

CHU Caen

Caen, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

Hôpital Henri Mondor AP-HP

Créteil, France

CHU Grenoble

Grenoble, France

CHU Lille

Lille, France

CHU Limoges

Limoges, France

CHU Lyon Sud

Lyon, France

IPC Marseille

Marseille, France

CHU Montpellier

Montpellier, France

CHRU Nancy

Nancy, France

CHU Nantes

Nantes, France

CHU Nice

Nice, France

Hôpital La Pitié Salpêtrière AP-HP

Paris, France

Hôpital Necker AP-HP

Paris, France

Hôpital Saint Louis AP-HP

Paris, France

Hôpital Saint-Antoine AP-HP

Paris, France

CHU Poitiers

Poitiers, France

CHU Rennes

Rennes, France

CHU Saint Etienne

Saint-Etienne, France

CHRU Strasbourg

Strasbourg, France

Oncopole Toulouse

Toulouse, France

CHRU Tours

Tours, France

Institut Gustave Roussy

Villejuif, France