Phase 2 Study Of Imetelstat for Patient With Myelodysplastic/Myeloproliferative Neoplasms
M.D. Anderson Cancer Center
Summary
To learn if imetelstat can help to control MDS/MPNs.
Description
Primary Objectives * To determine the safety and tolerability of imetelstat in MDS/MPN * To assess efficacy (overall response (OR) rate) of imetelstat in MDS/MPN based on 2015 MDS/MPN IWG response criteria. * Incidence of AEs, maximum tolerated dose (MTD) and changes in clinical laboratory values. * Measures of efficacy: overall response rate (ORR) defined as sum of CR + complete cytogenetic remission + partial remission + marrow response + clinical benefit according to the IWG 2015 MDS/MPN response criteria.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Age ≥18 years as MF and CMML are very rare diseases in the pediatric population. * Diagnosis of MDS/MPN according to WHO including: 1. CMML-1 or CMML-2 with resistance or intolerance to hydroxyurea (if myeloproliferative subtype defined by WBC \>13x109/L) or with no response or intolerance to 4 cycles of azacitidine or decitabine or relapse or progression after any number of cycles. CMML-1 Participants with Hgb \<11g/dL, TSS score 20 or splenomegaly (defined as \>5cm under the lower costal margin by physical exam or \>12cm by imaging) in which hydroxyurea or HMA ther…
Interventions
- DrugImetelstat
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas