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PR1 Vaccination in Myelodysplastic Syndrome (MDS)

This study has been terminated.
(The trial was ended per sponsor due to slow accrual rates.)
Sponsor:
Collaborator:
The Vaccine Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00893997
First received: May 4, 2009
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Myelodysplastic Syndrome
Intervention: Biological: PR-1 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
Recruitment Period: 01/09/07 through 03/24/08. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twelve patients were registered, two patients did not receive drug and were not included in the study group therefore ten patients were evaluable.

Reporting Groups
  Description
PR-1 Vaccine 4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.

Participant Flow:   Overall Study
    PR-1 Vaccine  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
PR-1 Vaccine 4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.

Baseline Measures
    PR-1 Vaccine  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: years]
Median ( Full Range ) 		  64  
  ( 46 to 84 )  
Gender  
[units: participants]
 		 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 		 
United States     10  



  Outcome Measures
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1.  Primary:   Patient Immunologic Response   [ Time Frame: 29 weeks ]

Measure Type Primary
Measure Title Patient Immunologic Response
Measure Description Patients assessed after 4th vaccination for immunologic response categorized as 'Immunologic-Responders' or 'Non-Responders.' Immune response defined as an increase of ≥ 0.5 PR1-HLA-A2 tetramer cells/μl compared to the pre study absolute PR1-HLA-A2 tetramer cells/μl. Time period 29 weeks after study entry, with week 0 corresponding to 1st injection, and 8th injection thus being given at week 25, 29 weeks corresponds to 13 weeks after receipt of a 4th injection.
Time Frame 29 weeks  
Safety Issue No  

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.
Analysis on patients treated; study terminated early.

Reporting Groups
  Description
PR-1 Vaccine 4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.

Measured Values
    PR-1 Vaccine  
Number of Participants Analyzed  
[units: participants]
 		  10  
Patient Immunologic Response  
[units: participants]
 		 
Immunological Response     3  
No Immunological Response     7  

No statistical analysis provided for Patient Immunologic Response



2.  Primary:   Number of Patients With Clinical Response   [ Time Frame: At 29 weeks ]

Measure Type Primary
Measure Title Number of Patients With Clinical Response
Measure Description Clinical response based on the International Working Group (IWG) Response Criteria in myelodysplastic syndromes (MDS): 'Complete Response' or Hematologic Improvement' and 'No Clinical Response'. Clinical responses as assessed by standard criteria with bone marrow biopsy, cytogenetic studies (standard chromosome banding) and molecular studies 3 weeks after the last vaccination.
Time Frame At 29 weeks  
Safety Issue No  

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.
Analysis on patients treated; study terminated early.

Reporting Groups
  Description
PR-1 Vaccine 4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.

Measured Values
    PR-1 Vaccine  
Number of Participants Analyzed  
[units: participants]
 		  10  
Number of Patients With Clinical Response  
[units: participants]
 		 
Complete Response     0  
Hematological Improvement     1  
No Clinical Response     9  

No statistical analysis provided for Number of Patients With Clinical Response




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


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Guillermo Garcia-Manero, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-7305
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00893997     History of Changes
Other Study ID Numbers: 2005-0913
Study First Received: May 4, 2009
Results First Received: March 17, 2011
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration