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Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosis
Bu çalışma, JAK2 V617F mutasyonu taşıyan miyelofibrozis (myelofibrosis) hastalarında Elotuzumab adlı ilacın kullanımını incelemektedir. Çalışmaya, JAK inhibitörü tedavisine uygun olmayan, orta veya daha yüksek riskli hastalığı olan yetişkinler katılmaktadır. Çalışma Faz 2 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Adults with JAK2 V617F+ primary myelofibrosis (PMF) or post-polycythemia vera (PV)/essential thrombocythemia myelofibrosis (ET-MF) who require treatment and have intermediate or higher risk disease (as assessed by the International Prognostic Scoring System for Myelodysplastic Syndrome \[IPSS\], Dynamic International Prognostic Scoring System \[DIPSS\], DIPSS-plus, Mutation-Enhanced Prognostic System for Transplant Age Patients with Primary Myelofibrosis \[MIPSS70\], MIPSS70-plus version \[v\] 2.0, or MYelofibrosis SECondary to PV and ET-Prognostic Model \[MYSEC-PM\]). The MYSEC-PM is to only be used for patients with post-PV/ET MF * Patients must not be candidates for JAK inhibitor therapy in the opinion of the treating physician * Bone marrow (BM) fibrosis grade 2 or 3 according to the European classification * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Karnofsky performance status \>= 60%) * Absolute neutrophil count \>= 0.5 x 10\^9/L * Direct bilirubin =\< 1.5 x institutional upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless felt to be due to liver involvement by MF/extramedullary hematopoiesis, in which case =\< 5 x institutional upper limit of normal is permissible * Creatinine =\< 2 x institutional upper limit of normal OR creatinine clearance \>= 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Ability to understand and the willingness to sign a written informed consent document * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after the last administration of elotuzumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of child-bearing potential must have a negative pregnancy test. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after the last administration of elotuzumab Exclusion Criteria: * Splenic irradiation within the preceding 4 months * Chemotherapy (other than hydroxyurea), interferons, IMiDs, danazol or other androgens, erythroid stimulating agents, or other MF-directed commercially available agents within 4 weeks prior to entering the study or those who have not recovered to baseline from adverse events due to agents administered more than 4 weeks earlier * Other investigational agents within 4 half-lives prior to study entry * History of allergic reactions attributed to compounds of similar chemical or biologic composition to elotuzumab * Patients with known central nervous system (CNS) involvement * Prior allogeneic hematopoietic cell transplantation (allo-HCT) for MF * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Known pregnancy or lactation * Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) positivity