RecruitingPhase 1Phase 2NCT05580861

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

64 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding sulfasalazine (a drug commonly used for arthritis and bowel disease) to standard chemotherapy can improve outcomes for older adults with newly diagnosed acute myeloid leukemia (AML), a serious blood cancer. **You may be eligible if...** - You are 60 years old or older - You have been newly diagnosed with AML (including AML that developed from a previous blood condition like MDS) - Your doctor believes you are well enough to receive intensive chemotherapy - Your liver function tests are within acceptable ranges **You may NOT be eligible if...** - You have already received significant treatment for AML (brief stabilizing treatment with hydroxyurea or steroids is acceptable) - Your liver function tests are significantly abnormal - Your overall health is too poor to receive intensive chemotherapy - You are allergic to sulfasalazine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSulfasalazine

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05580861

Related Trials

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment

NCT0495389721 locations

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

NCT0495391022 locations

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT05554406221 locations

Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

NCT06672146127 locations

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

NCT06317649222 locations