Study to Evaluate Imetelstat (JNJ- 63935937) in Subjects with International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplastic SyndromesMyelodysplastic syndrome, unspecifiedD46.9C15.378.190.625
- Registration Number
- RBR-9jqhyc
- Lead Sponsor
- Fundação Pio XII - Hospital de Câncer de Barretos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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: 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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method