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Brief Title: Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
Official Title: Phase I/II Clinical Trial Assessing the Combination of Sulfasalazine With Standard of Care Induction Therapy in Newly Diagnosed Acute Myeloid Leukemias (AML) Patients 60 Years or Older- the SALMA Study
Study ID: NCT05580861
Brief Summary: Acute myeloid leukemia (AML) is a heterogeneous clonal myeloid neoplasm where abnormal proliferation and impaired differentiation of hematopoietic stem and myeloid progenitor cells impedes normal hematopoiesis. Sulfasalazine (SSZ) is a broadly available, well tolerated anti-inflammatory medicine approved for the treatment of ulcerative colitis and rheumatoid arthritis. Intact SSZ, but not its metabolites 5-aminosalicylic acid and sulfapyridine, competitively inhibits xCT.21 SSZ is thus an ideal candidate for drug repurposing in AML.The purpose of this phase I study is to evaluate the safety and feasibility of such strategy, provide preliminary signals of efficacy, and identify potential biomarkers
Detailed Description:
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU Amiens, Amiens, , France
Hôpital Avicenne, Bobigny, , France
CHU Caen, Caen, , France
CHU Henri Mondor, Créteil, , France
Centre Hospitalier Lyon Sud, Lyon, Lyon, , France
Hôpital de la Conception, AP-HM, Marseille, , France
CHU Nice, Nice, , France
AP-HP Hôpital Saint Louis, Paris, , France
AP-HP Hôpital Cochin, Paris, , France
Centre Henri Becquerel, Rouen, , France
CHU Tours, Tours, , France
CH Mignot, Versailles, , France
Gustave Roussy, Villejuif, , France