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Addition of sulfalasazine to chemotherapy for the treatment of AML in the elderly
EU CTIS ID: 2024-513084-38-00
What this study is testing
Phase I To assess the safety, characterize the dose-limiting toxicities (DLTs), and identify the maximal tolerated dose (MTD), and recommended phase II dose (RP2D) of the combination of Sulfasalazine (SSZ) with Idarubicin (IDA) and Cytarabine (AraC) in patients with newly diagnosed non-favorable AML. Probability of DLT should not exceed 33% at the end of the induction cycle (EOI) of IDA-AraC + SSZ treatment (up to Day 42). Phase II To assess preliminarily the anti-leukemia efficacy of the combination of IDA-AraC + SSZ, mainly in phase II, in newly diagnosed non-favorable AML with reference from historical data on complete remission rate, and MRD.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 60 years or older
- With newly diagnosed 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
- Multiparameter Flow Cytometry detected at screening allowing and / or compatible with MFCM-based MRD monitoring defined according to ELN criteria (Phase II only)
- ECOG performance status ≤2
- AST and ALT ≤3.0 x upper the limit of normal (ULN) and total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia
You likely can't join if
- Myeloid Sarcoma with < 20% bone marrow blasts
- 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).
See the full eligibility criteria
Who can join
- Patients aged 60 years or older
- With newly diagnosed 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
- Multiparameter Flow Cytometry detected at screening allowing and / or compatible with MFCM-based MRD monitoring defined according to ELN criteria (Phase II only)
- ECOG performance status ≤2
- AST and ALT ≤3.0 x 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.
What rules you out
- Myeloid Sarcoma with < 20% bone marrow blasts
- 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
- Patient who has received a vaccine injection with live-attenuated virus in the last three weeks
- 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 LVEF <53% as assessed by echocardiography or 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 1/2 lives) days after the administration of the final dose of study medication.
- Proven central nervous system leukemic involvement
- 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 articles L 3212-1 and L3213-1 and who are not subject to the provisions of article L 1121
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.