Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Imetelstat 4.7 mg/kg
- drug: Imetelstat 9.4 mg/kg
Eligibility
Inclusion Criteria:
- Diagnosis of primary myelofibrosis (PMF) according to the revised WHO criteria; or
post-essential thrombocythemia-myelofibrosis (PET-MF) or post-polycythemia
vera-myelofibrosis (PPV-MF) according to the International Working
Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.
- Dynamic International Prognostic Scoring System (DIPSS) intermediate-2 or highrisk MF.
- Measurable splenomegaly prior to study entry as demonstrated by palpable spleen
measuring ≥ 5 cm below the left costal margin OR spleen volume of ≥ 450 cm^3 measured
by magnetic resonance imaging (MRI).
- Active symptoms of MF as demonstrated by a symptom score of at least 5 points (on a 0
to 10 scale) on at least one of the symptoms or a score of 3 or greater on at least 2
of the symptoms.
- Documented progressive disease during or after Janus kinase (JAK) inhibitor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Exclusion Criteria:
- Peripheral blood blast count of ≥ 10% or bone marrow blast count of ≥ 10%.
- Prior treatment with imetelstat.
- Any chemotherapy or MF-directed therapy, investigational drug, hydroxyurea,
immunomodulatory or immunosuppressive therapy, corticosteroids or JAK inhibitor
therapy ≤14 days prior to randomization.
- Major surgery within 4 weeks prior to randomization.
- Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus
are permitted to enter the study), of any type or known acute or chronic liver disease
including cirrhosis.
- Prior history of hematopoietic stem cell transplant.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.