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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minoo Battiwalla, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00433745
First received: February 9, 2007
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: April 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia (AML)
Chronic Myeloid Leukemia (CML)
Intervention: Drug: WT1 Peptide Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
WT1 Peptide Vaccine Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.

Participant Flow:   Overall Study
    WT1 Peptide Vaccine  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
WT1 Peptide Vaccine Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.

Baseline Measures
    WT1 Peptide Vaccine  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 18  
Gender  
[units: participants]
 
Female     3  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Cellular Immune Response   [ Time Frame: 7 weeks after last dose of vaccine ]

2.  Secondary:   Disease Response   [ Time Frame: 7 weeks after last dose of vaccine ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Although there was one partial response at 7 weeks, this patient went on to relapse as well.

Consequently, all 4 patients had rapid relapses despite vaccination. Accrual was stopped at 4.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Minoo Battiwalla, MD
Organization: Hematology Branch, NHLBI
phone: 301 827 0939
e-mail: battiwam@nhlbi.nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: Minoo Battiwalla, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00433745     History of Changes
Obsolete Identifiers: NCT00458965
Other Study ID Numbers: 070091, 07-H-0091
Study First Received: February 9, 2007
Results First Received: April 30, 2013
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration