drugset / Trial / NCT01266083

WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

NCT01266083

NaSingle-groupOpen-labelTreatment

Summary

This trial will assess the safety and efficacy of vaccination with galinpepimut-S (GPS), a WT1 peptide vaccine, in patients who are in complete remission from leukemia. Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease recurrence at Week 12 and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month.

Timeline

Start
2011-01-14
Primary completion
2016-09-30
Completion
2016-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Galinpepimut-S Vaccine Subcutaneous
Background sargramostim Protein / enzyme biologic 70 ug Subcutaneous