Imetelstat Sodium in Treating Patients with Primary or Secondary Myelofibrosis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-005104
NCT ID: NCT01731951
Sponsor Protocol Number: CP14B019
About this study
This pilot clinical trial studies how well imetelstat sodium works in treating patients with primary or secondary myelofibrosis. Imetelstat sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Study closed to enrollment
Inclusion Criteria:
- Diagnosis of one of the following:
- PMF per the revised World Health Organization (WHO) criteria
- Post-ET/PV MF per the IWG-MRT criteria
- High-risk or Intermediate-2 risk MF (as defined by the Dynamic International Prognostic Scoring System [DIPSS-plus])
- Life expectancy of ≥ 12 weeks
- Able to provide informed consent and be willing to sign an informed consent form
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
- Serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
- Total bilirubin ≤ 3.0 mg/dL (or direct bilirubin < 1 mg/dL)
- Creatinine ≤ 3.0 mg/dL
- Absolute neutrophil count ≥ 1000/uL
- Platelet count ≥ 50,000/uL
- Absence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULN
- Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to registration, unless they are surgically sterile for at least 3 months (i.e., hysterectomy), OR postmenopausal for at least 12 months (follicle-stimulating hormone [FSH] >30 U/mL)
- Females of childbearing potential must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study; permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed
- Males must agree to take appropriate precautions to avoid fathering a child (with at least 99% certainty) from screening through follow-up; permitted methods for preventing pregnancy should be communicated to the subjects and their understanding confirmed
Exclusion Criteria:
- Females who are pregnant or are currently breastfeeding
- Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, growth factor treatment (e.g., erythropoietin) or Janus kinase (JAK) inhibitor therapy ≤ 14 days prior to registration
- Subjects with another active malignancy
- Note: patients with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin or cervical intraepithelial neoplasia are eligible for enrollment
- Known positive status for human immunodeficiency virus (HIV)
- Any unresolved toxicity greater or equal to grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
- Incomplete recovery from any prior surgical procedures or had surgery ≤ 4 weeks prior to registration, excluding the placement of vascular access
- Presence of acute active infection requiring antibiotics
- Uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Ayalew Tefferi, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available