Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2023
décembre 2026
05 septembre 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | ITZYKSON Raphael | 18/10/2025 09:52:56 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | ITZYKSON Raphael | 18/10/2025 09:52:56 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/10/2025 09:52:57 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Louis | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Mignot - Versailles - France | Juliette Lambert, MD PhD | 18/10/2025 09:52:55 | Contact (sur clinicalTrials) | ||
| Hôpital Avicenne - Bobigny - France | Thorsten Braun, Pr | 18/10/2025 09:52:55 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP Hôpital Saint Louis - 75010 - Paris - France | Rapahël Irzykson, MD PhD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Emilie Lemasle, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon Sud, Lyon - Lyon - France | Mael Heiblig, Dr | Contact (sur clinicalTrials) | |||
| CHU Amiens - Amiens - France | Delphine Lebon, Dr | Contact (sur clinicalTrials) | |||
| CHU Caen - Caen - France | Sylvain Chantepie, Dr | Contact (sur clinicalTrials) | |||
| CHU Henri Mondor - Créteil - France | Mathieu Leclerc, Dr | Contact (sur clinicalTrials) | |||
| CHU Nice - Nice - France | Thomas Cluzeau, Pr | Contact (sur clinicalTrials) | |||
| CHU Tours - Tours - France | Emmanuel Gyan, Pr | Contact (sur clinicalTrials) | |||
| Gustave Roussy - Villejuif - France | Stephane de Botton, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de la Conception, AP-HM - Marseille - France | Geoffroy Venton, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients aged 60 years or older
- With newly diagnosed acute myeloid leukemia (AML) (short course treatment with
hydroxyurea and or steroids is acceptable). Patients with AML secondary to an
antecedent Myelodysplastic Syndromes (MDS) or Myeloproliferative Neoplasms (MPN) are
eligible, as those with therapy-related AML.
- Eligible for intensive chemotherapy in the investigator's opinion
- Leukaemia-associated immunophenotypes (LAIP) detected at screening allowing flow
cytometry (FCM)-based Minimal Residual Disease monitoring (Phase II only).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Aspartate transaminase (AST) and Alanine transaminanse (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
- Written informed consent obtained prior to any screening procedures
- Eligible for National Health Insurance in France
- Patients aged 60 years or older
- With newly diagnosed acute myeloid leukemia (AML) (short course treatment with
hydroxyurea and or steroids is acceptable). Patients with AML secondary to an
antecedent Myelodysplastic Syndromes (MDS) or Myeloproliferative Neoplasms (MPN) are
eligible, as those with therapy-related AML.
- Eligible for intensive chemotherapy in the investigator's opinion
- Leukaemia-associated immunophenotypes (LAIP) detected at screening allowing flow
cytometry (FCM)-based Minimal Residual Disease monitoring (Phase II only).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Aspartate transaminase (AST) and Alanine transaminanse (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
- Written informed consent obtained prior to any screening procedures
- Eligible for National Health Insurance in France
- Myeloid Sarcoma with < 20% bone marrow blasts
- Patient who has received a vaccine injection with live-attenuated virus in the last
three weeks
- Proven central nervous system leukemic involvement
- Favorable risk cytogenetics: t(15;17), t(8;21), inv(16) or t(16;16) or presence of
PML-RARA, RUNX1-RUNX1T1 or CBFB-MYH11 fusion transcript.
- Presence of FLT3-ITD or TKD mandating treatment with midostaurin.
- Concurrent therapy with any cytotoxic drug within 3 weeks before the first study
dose. Only hydroxyurea for the control of blood counts is permitted.
- Patients planned to received CPX-351 for myelodysplasia-related changes or
therapy-related AML.
Previous treatment with sulfasalazine in the last 5 years or ongoing treatment with
sulfasalazine or 5-aminosalicylic acid (5-ASA) for ulcerative colitis or inflammatory
rheumatisms.
- History of allergy SSZ, one of its metabolites (5-aminosalicylic acid, 5-ASA) or
mesalazine, other sulfonylarylamines sulfonamides or salicylates, or sulfasalazine
excipients History of allergic reaction to idarubicin or idarubicin excipients
- History of allergic reaction to cytarabine or cytarabine excipients
- Known glucose 6-phosphate dehydrogenase deficiency.
- Known acute intermittent porphyria or porphyria variegata.
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing
signs/symptoms related to the infection without improvement despite appropriate
treatment).
- Other uncontrolled or active malignant disease within prior 12 months (excluding
myelodysplastic syndrome; cutaneous basal cell carcinoma, "in-situ" carcinoma of the
cervix or breast, or other local malignancy excised).
- Known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
- Clinically active hepatitis B or hepatitis C infection.
- Inability to swallow. Known malabsorption syndrome or other condition that may
significantly impair absorption of oral study medications.
- Participation in another therapeutic interventional clinical study within 30 days of
enrolment.
- 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.
- Previous treatment by anthracyclines
- Any contraindication to use anthracyclines including uncontrolled coronary disease,
severe renal failure, severe hepatic failure, recent myocardial infarction,
symptomatic congestive heart failure, severe cardiomyopathy, significant arrhythmia
as estimated by the investigator or left-ventricule ejection fraction (LVEF) <53% as
assessed by echocardiography or Multigated Acquisition Scan (MUGA), anterior
treatment by idarubicin and/or anthracyclines and anthracènediones beyond the
maximum cumulative dose.
- Any contraindication to use cytarabine including degenerative and toxic
encephalopathy.
- Any condition requiring treatment with digoxin.
- Any of concurrent severe and/or uncontrolled medical condition, which could
compromise participation in the study.
- Females who are pregnant or breastfeeding.
- In a man whose sexual partner is a woman of childbearing potential, unwillingness or
inability of the man or woman to use a highly effective contraceptive method for the
entire treatment period and for at least 6 months after completion of protocol
treatment.
Highly effective contraception methods include: combined (estrogen and progestogen
containing) hormonal methods associated with inhibition of ovulation, intra-uterine
device; surgical sterilization (including bilateral tubal occlusion, partner's vasectomy)
or sexual abstinence if this is the preferred and usual lifestyle of the patient.
Male patients must not freeze or donate sperm starting at screening and throughout the
treatment period and 3 months after the administration of the final dose of study
medication.
- In a heterosexually active woman of childbearing potential, unwillingness or
inability to use a highly effective contraceptive method (as described above) for
the entire treatment period and for at least 6 months after the administration of
the final dose of study medication.
Women are not regarded as of childbearing potential if they are post-menopausal (at least
2 years without menses) or are surgically sterile (at least 1 month before enrollment).
Female patients must not donate or retrieve, for their own use, ova from the time of
screening and throughout the treatment period, and for 12 weeks after the administration
of the final dose of study medication.
Female patients must agree not to breastfeed from the time of screening and throughout
the protocol period, and for (5 half-lives) days after the administration of the final
dose of study medication.
Adults subjects to a legal protection order or unable to give their consent
- Persons deprived of their freedom by judicial or administrative decision, person
hospitalized without their consent by virtues of French Public Health Code articles
L 3212-1 and L3213-1 and who are not subject to the provisions of article L 1121-8.