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Clinical Trials in the EU / 2025-523632-39-00
Authorised Phase II

FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML

2025-523632-39-00 · tracked via the Priya Life Science EU tracker
Sponsor
Institut Paoli Calmettes
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Neoplasms
Decision date
17/08/2026
Enrollment target
77
Sites
France

Condition studied

acute myeloid lymphoma

Investigational medicinal product(s)

CICLOSPORINMYCOPHENOLATE MOFETILFludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusionCYCLOPHOSPHAMIDETrecondi 5 g powder for solution for infusion

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death

Endpoint detail

Conditioning related toxicity according to CTCAE, rate of graft failure, Cumulative incidence of neutrophil and platelet recovery, Cumulative incidence of acute GVHD, Cumulative incidence of chronic GVHD, Cumulative incidence of NRM, Probability of Overall Survival, Probability of GVHD, Prevalence of immunosuppressive therapy (IST) and GVHD at 3, 6, 9, 12 months

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523632-39-00 on CTIS ↗ ← All trials in the EU