Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosis (NCT04517851) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Elotuzumab for the Treatment of JAK2-Mutated Myelofibrosis
United States15 participantsStarted 2021-02-10
Plain-language summary
This phase II trial investigates how well elotuzumab works in treating patients with JAK2-mutated myelofibrosis. Elotuzumab may help to control myelofibrosis and/or help to improve blood cell count and bone marrow function.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 crea…
What they're measuring
1
Overall response (OR)
Timeframe: Up to completion of cycle 36 (1 cycle is 28 days)