Trial · NCT01266083

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

NCT01266083, Phase 2, Completed, Sellas Life Sciences Group; results first posted 2024-11-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). Trials, record NCT01266083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01266083

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
NCT number: NCT01266083
Status: Completed
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: Sellas Life Sciences Group
Conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Interventions: Galinpepimut-S, GM-CSF, Montanide
First posted: 2010-12-24
Last updated: 2024-11-19
Results first posted: 2024-11-19

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	3 years	OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more
Secondary	Progression-free Survival	5 years and 8 months	Time to PFS measured from first administration of GPS to relapse or death from any cause

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	3 years	Of the 22 patients, 19 (86.4%) were evaluable for survival at 3 years,	percentage of participants	NUMBER
SECONDARY	Progression-free Survival	5 years and 8 months		days	MEDIAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Galinpepimut-S + Montanide + GM-CSF		47		percentage of participants
Progression-free Survival	Galinpepimut-S + Montanide + GM-CSF		283	95% Confidence Interval 71 to NA	days

Source ClinicalTrials.gov

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Galinpepimut-S + Montanide + GM-CSF	22
Overall Study	Eligible for Additional Monthly Vaccinations After Initial 6 Vaccinations (Q2W)	Galinpepimut-S + Montanide + GM-CSF	13
Overall Study	COMPLETED	Galinpepimut-S + Montanide + GM-CSF	22
Overall Study	NOT COMPLETED	Galinpepimut-S + Montanide + GM-CSF	0

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Injection Site Reaction	General disorders	Galinpepimut-S + Montanide + GM-CSF	10	22
other	Skin Induration	Skin and subcutaneous tissue disorders	Galinpepimut-S + Montanide + GM-CSF	7	22
other	Fatigue	General disorders	Galinpepimut-S + Montanide + GM-CSF	7	22
other	Pruritus	Skin and subcutaneous tissue disorders	Galinpepimut-S + Montanide + GM-CSF	6	22
other	Lymphocyte Count Decreased	Investigations	Galinpepimut-S + Montanide + GM-CSF	6	22
other	Neutrophil Count Decreased	Investigations	Galinpepimut-S + Montanide + GM-CSF	6	22
other	White Blood Cell Count Decreased	Investigations	Galinpepimut-S + Montanide + GM-CSF	6	22
other	Platelet Count Decreased	Investigations	Galinpepimut-S + Montanide + GM-CSF	4	22
other	Pain	General disorders	Galinpepimut-S + Montanide + GM-CSF	3	22
other	Erythema Multiforme	Skin and subcutaneous tissue disorders	Galinpepimut-S + Montanide + GM-CSF	3	22

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Galinpepimut-S + Montanide + GM-CSF	10	22
Total, other adverse events	Galinpepimut-S + Montanide + GM-CSF	21	22
Total, serious adverse events	Galinpepimut-S + Montanide + GM-CSF	1	22

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29386195	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01266083

GET https://conductscience.org/api/trials/v1/NCT01266083/events?page=2

API reference For AI assistants