Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocy… (NCT02805868) | Clinical Trial Compass
WithdrawnEarly Phase 1
Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis
Stopped: Funding
0Started 2016-06
Plain-language summary
The main purpose of this investigational research study is to determine how safe and tolerable the study drug siltuximab is in patients with myelofibrosis (MF). This medication has been approved by the FDA for another condition (multicentric castleman's disease (MCD), but not for myelofibrosis (MF). In MCD, siltuximab resulted in improvement in symptoms and anemia. While MCD and MF are different diseases, they share some common features including a protein call interleukin-6 (IL-6) that may be important in causing symptoms of MCD and MF.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (post-PV) myelofibrosis (MF), or post-essential thrombocythemia (post-ET) MF using World Health Organization Criteria
* Patients must have disease that requires therapy, including intermediate-1, intermediate-2, or high-risk disease according to the International Prognostic Scoring System (IPSS) or Dynamic-IPSS
* Patients must be off myeloproliferative neoplasm (MPN) directed therapy, such as Janus kinase (JAK)-inhibitors, for at least 2 weeks prior to administration of the study drug; NOTE: This does not include supportive transfusion, or hydroxyurea; these must be stopped prior to first day of treatment, but no wash -out period is required
* Patients must be resistant to, intolerant of, or ineligible for JAK2 inhibitor therapy, based on severe anemia or thrombocytopenia
* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* New York Heart Association functional classification for congestive heart failure (NYHA CHF) \< 3
* Patients must have clinical laboratory values meeting the following criteria within 28 days prior to registration:
* Absolute neutrophil count \>= 1.0 x 10\^9/L (without growth factor support)
* Platelet count \>= 20 x 10\^9/L (without transfusion support within 2 weeks of registration)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of n…