PR1 Vaccination in Myelodysplastic Syndrome (MDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00893997
Recruitment Status : Terminated (The trial was ended per sponsor due to slow accrual rates.)
First Posted : May 6, 2009
Results First Posted : April 12, 2011
Last Update Posted : July 16, 2012
The Vaccine Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Myelodysplastic Syndrome
Intervention: Biological: PR-1 vaccine

  Participant Flow

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

Participant Flow:   Overall Study
    PR-1 Vaccine

  Baseline Characteristics

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

Baseline Measures
   PR-1 Vaccine 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (46 to 84) 
[Units: Participants]
Female   5 
Male   5 
Region of Enrollment 
[Units: Participants]
United States   10 

  Outcome Measures

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

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

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

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

Results Point of Contact:  
Name/Title: Guillermo Garcia-Manero, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-7305

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00893997     History of Changes
Other Study ID Numbers: 2005-0913
First Submitted: May 4, 2009
First Posted: May 6, 2009
Results First Submitted: March 17, 2011
Results First Posted: April 12, 2011
Last Update Posted: July 16, 2012