Trial · NCT00665002

Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms

NCT00665002, Not applicable, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2014-07-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms. Trials, record NCT00665002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00665002

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Trial

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

Title: Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms
NCT number: NCT00665002
Status: Completed
Phases: Not applicable
Enrollment: 16 participants, actual
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Conditions: Leukemia
Interventions: WT-1, Montanide, Sargramostim (GM-CSF)
First posted: 2008-04-23
Last updated: 2015-02-27
Results first posted: 2014-07-24

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 With Adverse Events (AEs)	12 weeks to 6 months	Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.
Secondary	Participants Whose Samples Demonstrated Immunological Response After Vaccination	12 weeks	Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well. ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release. Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion. Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders). Overall: any form of immune response.

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 With Adverse Events (AEs)	12 weeks to 6 months	All participants	participants	NUMBER
SECONDARY	Participants Whose Samples Demonstrated Immunological Response After Vaccination	12 weeks	All participants	participants	NUMBER

Source ClinicalTrials.gov

Results by group7

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

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events (AEs)	Experimental: WT-1 Analog Peptide Vaccine		15	participants
Participants Whose Samples Demonstrated Immunological Response After Vaccination	Experimental: WT-1 Analog Peptide Vaccine	CD4+ Immune Response	4	participants
Participants Whose Samples Demonstrated Immunological Response After Vaccination	Experimental: WT-1 Analog Peptide Vaccine	CD4+ and CD8+ Response	3	participants
Participants Whose Samples Demonstrated Immunological Response After Vaccination	Experimental: WT-1 Analog Peptide Vaccine	WT1 T Cell Expansion	2	participants
Participants Whose Samples Demonstrated Immunological Response After Vaccination	Experimental: WT-1 Analog Peptide Vaccine	Positive by ELISPOT and T Cell Expansion	2	participants
Participants Whose Samples Demonstrated Immunological Response After Vaccination	Experimental: WT-1 Analog Peptide Vaccine	Measurable DTH Response	2	participants
Participants Whose Samples Demonstrated Immunological Response After Vaccination	Experimental: WT-1 Analog Peptide Vaccine	Any form of Immune Response	6	participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental: WT-1 Analog Peptide Vaccine	16
Overall Study	COMPLETED	Experimental: WT-1 Analog Peptide Vaccine	4
Overall Study	NOT COMPLETED	Experimental: WT-1 Analog Peptide Vaccine	12

Source ClinicalTrials.gov

Adverse events63

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	Platelets - low	Blood and lymphatic system disorders	Experimental: WT-1 Analog Peptide Vaccine	10	16	16
other	Leukocytes (total WBC) - low	Blood and lymphatic system disorders	Experimental: WT-1 Analog Peptide Vaccine	4	16	5
other	Neutrophils/granulocytes (ANC/AGC) - low	Blood and lymphatic system disorders	Experimental: WT-1 Analog Peptide Vaccine	4	16	12
other	Hemoglobin - low	Blood and lymphatic system disorders	Experimental: WT-1 Analog Peptide Vaccine	3	16	7
other	Bone marrow cellularity	Blood and lymphatic system disorders	Experimental: WT-1 Analog Peptide Vaccine	1	16	1
other	Injection site reaction/extravasation changes	Skin and subcutaneous tissue disorders	Experimental: WT-1 Analog Peptide Vaccine	7	16	19
other	Dermatology/Skin - Other	Skin and subcutaneous tissue disorders	Experimental: WT-1 Analog Peptide Vaccine	3	16	3
other	Pruritus/itching	Skin and subcutaneous tissue disorders	Experimental: WT-1 Analog Peptide Vaccine	2	16	2
other	Rash: erythema multiforme	Skin and subcutaneous tissue disorders	Experimental: WT-1 Analog Peptide Vaccine	2	16	3
other	Bruising (in absence of Grade 3 or 4 thrombocytopenia)	Skin and subcutaneous tissue disorders	Experimental: WT-1 Analog Peptide Vaccine	1	16	2

1 to 10 of 63Source ClinicalTrials.gov

See all 63 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental: WT-1 Analog Peptide Vaccine
Total, other adverse events	Experimental: WT-1 Analog Peptide Vaccine	15	16
Total, serious adverse events	Experimental: WT-1 Analog Peptide Vaccine	2	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33394722	DERIVED

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/NCT00665002

GET https://conductscience.org/api/trials/v1/NCT00665002/events?page=2

API reference For AI assistants