CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Galinpepimut-S +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01266083
NCT01266083Phase 2Completed
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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)

Sellas Life Sciences Group·interventional·Posted Dec 24, 2010·Updated Nov 19, 2024

In Brief

A Phase 2 clinical trial evaluating Galinpepimut-S, GM-CSF, and 1 other intervention for Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia
CountriesUnited States
CollaboratorsMemorial Sloan Kettering Cancer Center

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartJan 14, 2011
Primary CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 15.5 years ago

Interventions

Galinpepimut-Sbiological

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

GM-CSFbiological

subcutaneous injection

Montanideother

adjuvant