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RECRUITING
NCT05580861
PHASE1/PHASE2

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2023-05-17

Completion Date

2026-12

Last Updated

2024-05-29

Healthy Volunteers

No

Interventions

DRUG

Sulfasalazine

Sulfazalazine 500mg-tablets ; 7 dose levels explored in the phase I part of the trial.

Locations (13)

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