OncoMatch/Clinical Trials/NCT05580861
Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
Is NCT05580861 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05580861 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior sulfasalazine, 5-aminosalicylic acid, anthracycline disqualifies patients from enrollment.
Are patients with PML alterations eligible?
No. PML PML-RARA fusion transcript is an exclusion criterion.
Are patients with RUNX1 alterations eligible?
No. RUNX1 RUNX1-RUNX1T1 fusion transcript is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages