haematological maligancy
Conditions
Interventions
S80880 will be administered by continuous IV infusion from day 1 through day 4
of each week during the first 4-week cycle. Patients who then qualify for
subsequent cycles will be given S80880 accord
Sponsors
Institut de Recherches Internationales Servier I.R.I.S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - male or female > or or
Exclusion criteria
Exclusion criteria: Diagnosis of myeloid sarcoma, History of other malignancy within 3 years prior to start of protocol-specified therapy (exceptions: see protocol) Patients who have not recovered from toxicity of previous antileukaemic therapy, including grade * 2 non-haematologic toxicity, prior to starting the test drug, Patients previously treated by anti-CD123 therapy, Any previous anticancer treatment for leukaemic disease within at least 2 weeks, Previous radiotherapy or immunotherapy in the 4 weeks prior to first IMP intake, Patients with previous history of allogeneic stem cell transplantation; Any prior history of or suspected current autoimmune disorders (exceptions: see protocol), Severe uncontrolled fungal, bacterial or viral infection, Leukaemic central nervous system involvement, Pregnant or breastfeeding women, known hypersensitivity to murine or recombinant proteins, polysorbate 80, recombinant human serum albumin, benzyl alcohol or any excipient contained in the S80880 drug formulation, history of Quincke oedema, Known infection with human immunodeficiency virus (HIV), infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive), Any other diseases (e.g. adrenal insufficiency, malabsorption syndromes, metabolic dysfunction, physical examination finding), or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for test drug complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary endpoint is occurance of DLT (dose limiting toxicity) during cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points: Safety profile of S80880 assessed by: * All adverse events * All serious adverse events * Laboratory tests (haematology, blood biochemistry, coagulation, urinary analysis, pregnancy test) * Vital signs and performance status * Clinical examination * ECG parameters, cardiac function assessment PK profile parameters of S80880 in serum Response rate (any CR, PR or HI) as determined by investigator, using the response criteria proposed by the International working Group for MDS, using adapted criteria proposed by the International working Group for AML, B-ALL, ALAL and BPDCN, - Response duration, - Event-free survival, - Overall survival. | — |
Countries
Netherlands
Outcome results
None listed