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To assess the safety and efficacy of galinpepimut-S compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second complete remission 2 (CR2)/second complete remission with incomplete platelet recovery (CR2p).
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best available treatment (BAT) in patients with AML in second complete remission (CR2) or in second complete remission with incomplete platelet recovery (CRp2). All patients will have bone marrow samples stained for WT1 via IHC by central pathology review. The primary goal of the study will be to demonstrate an advantage for GPS in overall survival in these patient populations. The study will enroll approximately 116 patients and will be conducted at up to 50 investigational sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are in CR2 or CRp2.
Patients on the BAT arm may be treated with 1. observation (whereby palliative management with hydroxyurea is allowed), 2. a hypomethylating agent (decitabine or azacitidine), 3. Venetoclax monotherapy or 4. low-dose ara-C monotherapy. Patients whose remission is maintained with other agents (e.g. FLT-3 or IDH inhibitors) will not be eligible.
Patients on the GPS arm will receive 70 μg of sargramostim (GM- CSF) on Day -2 and Day 1 before each injection of GPS. The first two administrations of GM-CSF will take place at the same anatomical site as the planned administration of GPS within each treatment cycle. GPS will be administered as an immunization induction every 2 weeks for 6 administrations (Weeks 0 - 10); this will be followed by a 4-week period of no treatment. Treatment will then resume for 6 administrations as an initial booster phase every 4 weeks (Weeks 14 - 34) which will again be followed by a period of no treatment lasting 6 weeks. GPS will be resumed after this period as a second booster phase and will be administered every 6 weeks for 3 administrations (Weeks 40 - 52). Following each administration of GM-CSF or GPS, patients will remain in the clinic for approximately 30 minutes for observation. An End of Treatment visit will be conducted 30 days following the last dose of GPS. Patients will then enter the long-term follow-up portion of the trial where they will be followed for recurrence of leukemia and overall survival.
Acute Myeloid Leukemia
Galinpepimut-S, Best Available Therapy
HonorHealth Virginia G. Piper Cancer Care Network
Sellas Life Sciences Group
Published on BioPortfolio: 2020-01-19T11:04:34-0500
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