At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of Philadelphia chromosome-negative MPN including CNL, aCML, CMML, MPN/MDS overlap, accelerated phase myelofibrosis, or MPN unclassifiable per WHO classification
- ✓Age minimum 18 years
- ✓ECOG performance status less than 3
- ✓Total bilirubin ≤1.5X institutional upper limit of normal (unless attributable to underlying disease, hemolysis, or documented Gilbert's syndrome)
- ✕Any chemotherapy (investigational or FDA-approved) or radiotherapy within 2 weeks prior to study entry (hydroxyurea permitted)
- ✕Concurrent investigational agents (other than SGI-110) unless approved by principal investigator and sponsors of both agents
- ✕History of allergic reactions to compounds of similar chemical or biologic composition to decitabine or SGI-110
- ✕Uncontrolled intercurrent illness including infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of SGI-110 in Philadelphia-Negative Myeloproliferative Neoplasms
In Brief
A Phase 2 clinical trial evaluating SGI-110 for Myeloproliferative Neoplasms. Completed, enrolled 22 participants across 1 site.
Detailed Summary
* This is an open label single-arm, single-institution stud to evaluate the efficacy and safety of SGI-110 in Philadelphia chromosome negative (Ph-) Myeloproliferative Neoplasms (MPN) (excluding PV, ET and primary/secondary myelofibrosis). The study will enroll approximately 50 patients at the Weill Cornell Medical College. * Enrollment onto this clinical study is expected to be completed in approximately 36 months. The total study duration will depend on individual response, evidence of disease progression and tolerance. Participants will be followed monthly for six months after removal from study or until death, whichever occurs first. Key eligibility: * Confirmed diagnosis of Ph- MPN and had * No chemotherapy or radiation treatment within 2 weeks prior to study entry. * Subjects meet other protocol-defined criteria related to baseline screening procedures.
Study Details
Timeline
Interventions
subcutaneously at a dose of 60 mg/m2