BridgeMD
New treatment option for Acute Myeloid Leukemia
Official title Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment
ClinicalTrials.gov ID: NCT05580861
What this study is testing
What is Sulfasalazine?
Sulfasalazine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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 treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bobigny, France
- Caen, France
- Créteil, France
- Lyon, France
- Marseille, France
- Nice, France
- Paris, France
- Rouen, France
- Tours, France
- Versailles, France
- Villejuif, France
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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bobigny, France; Caen, France; Créteil, France; Lyon, France; Marseille, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.