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| ID | Type | Description | Link |
|---|---|---|---|
| HEMMDS0023 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
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This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Hematologic responses | Marrow blast decrement | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
Prior history of leukemia or aplastic anemia
Prior history of bone marrow transplantation
Platelet count <100,000/mm^3
*Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization
Active or uncontrolled infections
Unstable angina, congestive heart failure [NYHA>classII], uncontrolled hypertension [diastolic >100mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
Less than 4 weeks since receipt of any investigational product or device
Pregnant or breast feeding
Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
Previously enrolled in this study
Will not be available for follow-up assessments
Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
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Diagnosis of IPSS Intermediate or High risk MDS
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| Name | Affiliation | Role |
|---|---|---|
| Peter L Greenberg | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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marrow and peripheral blood