NCT05580861

Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Sulfasalazine	Sulfazalazine 500mg-tablets ; 7 dose levels explored in the phase I part of the trial.

Timeline

• Start date: 2023-05-17
• Primary completion: 2025-11-01
• Completion: 2026-12-01
• First posted: 2022-10-14
• Last updated: 2024-05-29

Locations

13 sites across 1 country: France