OncoMatch/Clinical Trials/NCT05580861
Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
Is NCT05580861 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Sulfasalazine for acute myeloid leukemia.
Treatment: Sulfasalazine — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: PML PML-RARA fusion transcript
presence of PML-RARA
Excluded: RUNX1 RUNX1-RUNX1T1 fusion transcript
presence of RUNX1-RUNX1T1
Excluded: CBFB CBFB-MYH11 fusion transcript
presence of CBFB-MYH11
Excluded: FLT3 ITD or TKD mutation mandating treatment with midostaurin
Presence of FLT3-ITD or TKD mandating treatment with midostaurin
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: sulfasalazine (sulfasalazine)
Previous treatment with sulfasalazine in the last 5 years or ongoing treatment with sulfasalazine
Cannot have received: 5-aminosalicylic acid (5-aminosalicylic acid, 5-ASA)
ongoing treatment with 5-aminosalicylic acid (5-ASA) for ulcerative colitis or inflammatory rheumatisms
Cannot have received: anthracycline
Previous treatment by anthracyclines
Cannot have received: cytarabine (cytarabine)
Any contraindication to use cytarabine
Cannot have received: CPX-351 (CPX-351)
Patients planned to received CPX-351 for myelodysplasia-related changes or therapy-related AML
Cannot have received: cytotoxic chemotherapy
Exception: Only hydroxyurea for the control of blood counts is permitted
Concurrent therapy with any cytotoxic drug within 3 weeks before the first study dose. Only hydroxyurea for the control of blood counts is permitted.
Cannot have received: investigational therapy
Administration of any therapy considered investigational (i.e., used for non-approved indications(s) or in the context of a research investigation) within 5 drug half-lives (whichever is longer) prior to the first dose of study drug.
Lab requirements
Kidney function
Estimated GFR ≥ 50 mL/min according to the MDRD equation
Liver function
AST and ALT ≤ 3.0 x ULN; total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia
AST and Alanine transaminase (ALT) ≤ 3.0 times upper the limit of normal (ULN) and total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the MDRD equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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