Myelodysplastic Syndromes
Conditions
Interventions
Imetelstate Group (134 participants)- Each treatment cycle consists of 4 weeks (28 days).The initial dose of imetelstat is 7.5 mg / kg every 4 weeks. If, after at least 3 cycles of treatment, nadir va
Placebo group (66 participants) - placebo administration every 4 weeks and supportive treatment, including transfusions and myeloid growth factors, will be administered as needed, with researcher's di
Drug
Device
Sponsors
Fundação Pio XII - Hospital de Câncer de Barretos
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Man woman greater than or equal to (>=) 18 years of age; Diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria or French- American-British (FAB) classification confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Study Entry. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be reviewed and approved by the sponsor; International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS; Red blood cell (RBC) transfusion dependent, defined as requiring 4 units RBC over 8 weeks during the 12 weeks prior to Study Entry; pretransfusion hemoglobin (Hb) should be less than equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total; Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients; Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study; Prior treatment with imetelstat; Have received any chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 milligram per day prednisone or equivalent, or growth factor treatment within 28 days prior to study entry; Have received other treatments for MDS within 4 weeks prior to Study Entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint of this study is the IT RBC rate lasting at least eight weeks. The TI CBR rate of 8 weeks is defined as the percentage of participants without RBC transfusion during any 8 consecutive weeks from Day 1 of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-week RBC TI rate, defined as the proportion of subjects without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1;;Time to the 8-week RBC TI, defined as the interval from Study Day 1 to the first day of the first 8-week RBC TI period;;Duration of RBC TI, defined as the first day of the first 8-week RBC TI period to the date of the first RBC transfusion after the TI period;OS, defined as the interval from Study Day 1 to death from any cause. Survival time of living subjects will be censored on the last date a subject is known to be alive or lost to follow-up | — |
Countries
Belgium, Brazil, France, Netherlands, Russian Federation, Spain, United States
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed