At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of primary myelofibrosis (PMF) or secondary MF (post-ET or post-PV) per WHO/IWG-MRT criteria
- ✓DIPSS intermediate-2 or high-risk disease
- ✓Measurable splenomegaly: palpable spleen ≥5 cm below left costal margin OR spleen volume ≥450 cm³ on MRI
- ✓Active MF symptoms: score ≥5 on one symptom or ≥3 on at least two symptoms (0–10 scale)
- ✕Peripheral blood blasts ≥10% or bone marrow blasts ≥10%
- ✕Prior treatment with imetelstat
- ✕Active systemic hepatitis infection requiring treatment or known acute/chronic liver disease including cirrhosis
- ✕Prior hematopoietic stem cell transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor
In Brief
A Phase 2 clinical trial evaluating Imetelstat 4.7 mg/kg and Imetelstat 9.4 mg/kg for Myelofibrosis. Completed, enrolled 107 participants across 72 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) whose disease is relapsed after or is refractory to Janus Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.
Study Details
Timeline
Interventions
Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle. Study drug was administered intravenously until disease progression, unacceptable toxicity, or study end.
Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end.