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Trial record 8 of 24 for:    WAGR

Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers

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.
ClinicalTrials.gov Identifier: NCT00488592
Recruitment Status : Completed
First Posted : June 20, 2007
Results First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome (MDS)
Acute Myeloid Leukemia (AML)
Chronic Myeloid Leukemia (CML)
Interventions: Biological: WT1:126-134
Biological: PR1:169-177 Peptide
Drug: GM-CSF (Sargramostim)
Biological: Montanide adjuvant

  Participant Flow

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/PR1 Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention

Participant Flow:   Overall Study
    WT1/PR1
STARTED   10 [1] 
COMPLETED   7 [2] 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Disease progression                1 
Enrolled but not treated                1 
[1] 10 subjects were accrued
[2] 7 completed the initial series of 6 vaccinations



  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
  Description
WT1/PR1 Vaccine Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention

Baseline Measures
   WT1/PR1 Vaccine 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.9  (13.7) 
Gender 
[Units: Participants]
 
Female   7 
Male   3 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures

1.  Primary:   Efficacy in Inducing or Boosting a Cellular Immune Response   [ Time Frame: 16 weeks ]

2.  Secondary:   Clinical Response   [ Time Frame: 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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

Although not tested or described formally, no clinically meaningful hematological responses were seen.

Despite boosting, cellular immune responses were only transient.



  More Information

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 of Results:

Responsible Party: Minoo Battiwalla, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00488592     History of Changes
Obsolete Identifiers: NCT00499772
Other Study ID Numbers: 070159
07-H-0159 ( Other Identifier: National Heart Lung and Blood Institute )
First Submitted: June 19, 2007
First Posted: June 20, 2007
Results First Submitted: April 30, 2013
Results First Posted: July 9, 2014
Last Update Posted: July 9, 2014