Myelodysplastic syndromes MedDRA version: 12.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: CEPLENE
Pharmaceutical Form: Solution for injection
Trade Name: Proleukin
Pharmaceutical Form: Solution for injection
Trade Name: azacititine (Vidaza®)
Pharmaceutical Form: Solution for
Sponsors
Groupe Francophone des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age = 18 years 2.Must understand and voluntarily sign an informed consent form 3.Must be able to adhere to the study visit schedule and other protocol requirements 4.Documented diagnosis of MDS according to WHO classification, that meets IPSS criteria for intermediate-2 or high-risk disease 5.Must have achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria) after 6 cycles of Azacitidine. 6.Patients must have ECOG performance status (PS) of 0 – 2. 7.Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded. Creatinine clearance >50 ml/min 8. Creatinine clearance >50 ml/min 9.Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C 2.Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 3.Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy 4.Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities 5.Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years 6.Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease 7.History of seizures, central nervous disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the investigator 8.Prior history of autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis) 9.Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history of bleeding 10.Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents 11.Patients with a history of hypersensitivity to histamine or histamine products, severe allergies to food or contrast media requiring treatment within the last five years 12. Antecedent of allogeneic bone marrow transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is time to progression according to IWG 2006 criteria The appearance of progression will be assessed by monitoring the bone morrow, blood and hematologic supportive care;Main Objective: For the Phase I study: To evaluate the safety and tolerability of vidaza and Ceplene/IL-2 used together. For the phase II study: To determine if maintenance treatment with vidaza and Ceplene/IL-2 can improve, compared to maintenance treatment with vidaza alone, the time to progression in adult patients with higher risk MDS who achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria) after 6 cycles of vidaza. ;Secondary Objective: Secondary objectives 1.Characterize the safety profile and the tolerability of AZA when used together with Ceplene/IL-2 2.Determine if maintenance with AZA and Ceplene/IL-2 can improve the quality of responses compared to maintenance with AZA alone Determine if maintenance with AZA and Ceplene/IL-2 can increase the duration of responses compared to maintenance with AZA alone. Secondary endpoints: comparison of the 2 treatment arms for -safety -improvement of responses (from HI to PR or CR, according to IWG 2006 criteria) beyond 6 cycles -response duration -survival | — |
Countries
France
Outcome results
None listed