Trial Outcomes & Findings for Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy (NCT NCT00433745)

Results Overview

Minimum criterion for a cellular immune response was defined as the emergence of detectable T cell frequency against Willm's tumor 1 (WT1) when the pre-study analysis found no response, or a twofold increase in T cell frequency at any post vaccination time point

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

7 weeks after last dose of vaccine

Results posted on

2014-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	WT1 Peptide Vaccine Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WT1 Peptide Vaccine n=4 Participants Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 weeks after last dose of vaccine

Minimum criterion for a cellular immune response was defined as the emergence of detectable T cell frequency against Willm's tumor 1 (WT1) when the pre-study analysis found no response, or a twofold increase in T cell frequency at any post vaccination time point

Outcome measures

Outcome measures
Measure	WT1 Peptide Vaccine n=4 Participants Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Cellular Immune Response	4 participants

SECONDARY outcome

Timeframe: 7 weeks after last dose of vaccine

Clinical response of underlying malignancy to the vaccination

Outcome measures

Outcome measures
Measure	WT1 Peptide Vaccine n=4 Participants Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Disease Response Complete response	0 participants
Disease Response Partial response	1 participants
Disease Response No response	3 participants

Adverse Events

WT1 Peptide Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Minoo Battiwalla, MD

Hematology Branch, NHLBI

Phone: 301 827 0939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place