Trial · NCT00488592

Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers

NCT00488592, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2014-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers. Trials, record NCT00488592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00488592

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Trial

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

Title: Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers
NCT number: NCT00488592
Status: Completed
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Conditions: Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML)
Interventions: WT1:126-134, PR1:169-177 Peptide, GM-CSF (Sargramostim), Montanide adjuvant
First posted: 2007-06-20
Last updated: 2021-07-12
Results first posted: 2014-07-09

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Experienced Inducing or Boosting of a Cellular Immune Response	16 weeks	Number of participants diagnosed with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML) who experienced an inducing or boosting of a cellular immune response following Wilm's Tumor 1 (WT1) and PR1 vaccine. A T-cell immune response was considered positive if the frequencies of interferon (IFN-γ+) cluster of differentiation (CD8+) T cells in peptide-stimulated peripheral bloody mono-nucleated cells (PBMCs) were 2-fold or more higher than the frequencies of interferon (IFN-γ+) CD8+ T cells in unstimulated PBMCs and if there was a minimum of 0.05% Interferon (IFNγ+) CD8+ T cells (after subtracting the frequencies of interferon (IFNγ+) CD8+ T cells in unstimulated PBMCs). A significant vaccine-induced CD8+ T-cell response was defined as the emergence of detectable PR1 or WT1-specific CD8+ T cells when the pre-study analysis found no response, or a 2-fold increase in frequencies when responses were present before vaccination.
Secondary	Number of Participants Who Experienced a Hematological Response	16 weeks	Number of participants diagnosed with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML) who experienced a hematological response following Wilm's Tumor (WT1) and PR1 peptide vaccine. Hematological response is defined by reduction in marrow blast cells, changes in blood counts.

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	Number of Participants Who Experienced Inducing or Boosting of a Cellular Immune Response	16 weeks		participants	NUMBER
SECONDARY	Number of Participants Who Experienced a Hematological Response	16 weeks		participants	NUMBER

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Category	Value	Units
Number of Participants Who Experienced Inducing or Boosting of a Cellular Immune Response	PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers	Cellular immune response	5	participants
Number of Participants Who Experienced Inducing or Boosting of a Cellular Immune Response	PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers	No cellular immune response	2	participants
Number of Participants Who Experienced a Hematological Response	PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers		0	participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers	10
Overall Study	COMPLETED	PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers	7
Overall Study	NOT COMPLETED	PR1/WT1 Vaccine Response in Participants With Low-Risk Myeloid Cancers	3

Source ClinicalTrials.gov

Adverse events14

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	Events
other	decreased hemoglobin	Blood and lymphatic system disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	1	10	1
other	back pressure	Immune system disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	2	10	2
other	fatigue	General disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	1	10	1
other	lightheadness	General disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	1	10	1
other	malaise	General disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	1	10	1
other	rigors	General disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	1	10	1
other	skin rash	Skin and subcutaneous tissue disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	4	10	4
other	indigestion	Gastrointestinal disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	1	10	1
other	loose stools	Gastrointestinal disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	2	10	2
other	arthralgia	Musculoskeletal and connective tissue disorders	PR1/WT1 Vaccine Response in Participants With Leukemias	4	10	4

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PR1/WT1 Vaccine Response in Participants With Leukemias	0	10
Total, other adverse events	PR1/WT1 Vaccine Response in Participants With Leukemias	4	10
Total, serious adverse events	PR1/WT1 Vaccine Response in Participants With Leukemias	2	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21134985	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/NCT00488592

GET https://conductscience.org/api/trials/v1/NCT00488592/registered

API reference For AI assistants