Actively Recruiting
Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-29
64
Participants Needed
13
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 60 years or older
- Newly diagnosed acute myeloid leukemia (AML), including secondary AML from myelodysplastic syndromes or myeloproliferative neoplasms and therapy-related AML
- Eligible for intensive chemotherapy according to the investigator
- Presence of leukemia-associated immunophenotypes allowing minimal residual disease monitoring (phase II only)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Liver function tests (AST and ALT) no more than 3 times the upper normal limit and bilirubin no more than 1.5 times the upper normal limit unless due to leukemia
- Estimated glomerular filtration rate (GFR) of at least 50 mL/min
- Written informed consent obtained before any screening
- Eligible for National Health Insurance in France
You will not qualify if you...
- Myeloid sarcoma with less than 20% bone marrow blasts
- Recent live-attenuated vaccine within three weeks
- Central nervous system involvement by leukemia
- Favorable risk cytogenetics or presence of specific fusion transcripts (PML-RARA, RUNX1-RUNX1T1, CBFB-MYH11)
- Presence of FLT3 mutations requiring midostaurin treatment
- Cytotoxic therapy within three weeks prior to study drug except hydroxyurea
- Planned treatment with CPX-351 for myelodysplasia-related or therapy-related AML
- Previous or ongoing sulfasalazine or 5-aminosalicylic acid treatment within five years
- Allergy history to sulfasalazine, its metabolites, or related compounds
- Allergy history to idarubicin or cytarabine or their excipients
- Known glucose 6-phosphate dehydrogenase deficiency
- Known acute intermittent porphyria or porphyria variegata
- Uncontrolled systemic infections despite treatment
- Other active malignancies within 12 months except specific local cancers
- Known HIV infection or related malignancies
- Active hepatitis B or C infection
- Inability to swallow or malabsorption affecting oral medication
- Participation in another interventional study within 30 days
- Recent investigational therapy within 5 drug half-lives
- Prior anthracycline treatment
- Contraindications to anthracyclines or cytarabine including certain heart, kidney, or brain conditions
- Need for digoxin treatment
- Severe uncontrolled medical conditions
- Pregnant or breastfeeding females
- Unwillingness or inability to use effective contraception during treatment and specified follow-up periods
- Legal protection status preventing consent or inability to give informed consent
- Persons deprived of freedom by judicial or administrative decisions not covered by specific French Public Health Code provisions
AI-Screening
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Trial Site Locations
Total: 13 locations
1
CHU Amiens
Amiens, France
Not Yet Recruiting
2
Hôpital Avicenne
Bobigny, France
Not Yet Recruiting
3
CHU Caen
Caen, France
Not Yet Recruiting
4
CHU Henri Mondor
Créteil, France
Actively Recruiting
5
Centre Hospitalier Lyon Sud, Lyon
Lyon, France
Actively Recruiting
6
Hôpital de la Conception, AP-HM
Marseille, France
Not Yet Recruiting
7
CHU Nice
Nice, France
Actively Recruiting
8
AP-HP Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
9
AP-HP Hôpital Cochin
Paris, France, 75014
Actively Recruiting
10
Centre Henri Becquerel
Rouen, France
Not Yet Recruiting
11
CHU Tours
Tours, France
Actively Recruiting
12
CH Mignot
Versailles, France
Actively Recruiting
13
Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
R
Raphaël Itzykson, Pr
CONTACT
J
Jérôme Lambert, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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