NCT01266083

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

Phase 2 Trial of a WT1 Analog Peptide Vaccine in Patients in Complete Remission (CR) From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sellas Life Sciences Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical study is conducted in patients in complete remission from acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The primary objective is to assess the effect of vaccination with galinpepimut-S (GPS) on patient survival and the safety profile. Galinpepimut-S (GPS) consists of four WT1-derived peptides which have been chosen to strengthen antigenicity, but also broaden immunogenicity over a wide range of HLA subtypes, being able to stimulate both CD8+ (MHC Class I)- and CD4+ (MHC Class II)-dependent responses. Galinpepimut-S is administered with the adjuvant Montanide and sargramostim (GM-CSF). 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 evaluation and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month. Following the last vaccination, participants will be followed regularly (every 1 to 3 months) in an outpatinet setting for up to 3 years from the first treatment date.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Galinpepimut-S	Galinpepimut-S admixed with the adjuvant Montanide following specified schedule
BIOLOGICAL	GM-CSF	subcutaneous injection
OTHER	Montanide	adjuvant

Timeline

• Start date: 2011-01-14
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2010-12-24
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

1 site across 1 country: United States