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

NCT01266083 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-11-19

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Galinpepimut-S

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

BIOLOGICAL

GM-CSF

subcutaneous injection

OTHER

Montanide

adjuvant

Sponsors & Collaborators

Principal Investigators

  • Peter Maslak, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266083 on ClinicalTrials.gov