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

Recruiting Phase 3 Interventional Study
GVHD
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
324 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 co…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 50 and ≤ 70 years 2. Patient between 50 and 55 years should be unfit for a myeloblative conditioning (SORROR score ≥2) 3. AML requiring allogeneic stem cell transplantation (intermediate or high-risk AML) in complete cytologic response (CR1 or above) or MDS requiring al…
Contacts

Régis Peffault de Latour, Pr

+33142385073

regis.peffaultdelatour@aphp.fr

CONTACT

Jérôme Lambert, Dr

+33142499742

jerome.lambert@u-paris.fr

CONTACT