Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06083129
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Régis Peffault de Latour, Pr
Phone +33142385073
Email regis.peffaultdelatour@aphp.fr
Status Not yet recruiting
Phase Phase 3
Start date November 1, 2023
Completion date November 1, 2028

See also
  Status Clinical Trial Phase
Completed NCT02942173 - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT Phase 2/Phase 3
Completed NCT02066051 - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD N/A
Terminated NCT01940796 - Phase I Trial of Brentuximab Vedotin for Refractory Chronic Graft-vs.-Host Disease (GVHD) Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT01295710 - Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) Phase 3
Not yet recruiting NCT06075225 - MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib Phase 2
Not yet recruiting NCT06000982 - Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis Phase 3
Active, not recruiting NCT03680092 - Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation Phase 2
Not yet recruiting NCT05094765 - Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD Early Phase 1
Active, not recruiting NCT05415410 - Proof-of-concept Trial of Apraglutide in GVHD Phase 2
Completed NCT02441075 - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014 N/A
Completed NCT02588339 - Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention Phase 2
Not yet recruiting NCT06334367 - Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT Phase 2
Completed NCT03846479 - Itacitinib for Low Risk GVHD Phase 2
Completed NCT02891603 - A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression Phase 1/Phase 2
Completed NCT02712762 - Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
Completed NCT03945591 - High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Phase 2
Not yet recruiting NCT06411184 - Safety and Efficacy of Treg Cell in the Treatment of GVHD Phase 1/Phase 2
Terminated NCT02338232 - Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation N/A
Completed NCT02156479 - Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients