Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00433745
Recruitment Status : Completed
First Posted : February 12, 2007
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Minoo Battiwalla, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
Acute Myeloid Leukemia (AML)
Chronic Myeloid Leukemia (CML)
Intervention Drug: WT1 Peptide Vaccine
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title WT1 Peptide Vaccine
Hide Arm/Group Description Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title WT1 Peptide Vaccine
Hide Arm/Group Description Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
54  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
3
  75.0%
Male
1
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Cellular Immune Response
Hide Description 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
Time Frame 7 weeks after last dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title WT1 Peptide Vaccine
Hide Arm/Group Description:
Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Disease Response
Hide Description Clinical response of underlying malignancy to the vaccination
Time Frame 7 weeks after last dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title WT1 Peptide Vaccine
Hide Arm/Group Description:

All 4 patients who were accrued went on to receive the vaccine.

Complete Response (CR): defined as an absolute neutrophil count of ≥500/µL, platelet count of ≥75,000/µL, no leukemic blasts in the blood nor evidence of extramedullary leukemia, bone marrow (BM) with a cellularity of more than 20%, maturation of all three cell lineages, no Auer rods, and less than 5% bone marrow blast cells.

Partial response (PR): 50% reduction in marrow blasts, with an absolute neutrophil count (ANC) greater than 500/µL, and platelet count greater than 75000/µL.

No response: subjects who did not meet the above response criteria were defined as non-responders.

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Complete response 0
Partial response 1
No response 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title WT1 Peptide Vaccine
Hide Arm/Group Description All 4 patients who were accrued went on to receive the vaccine
All-Cause Mortality
WT1 Peptide Vaccine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
WT1 Peptide Vaccine
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
WT1 Peptide Vaccine
Affected / at Risk (%)
Total   0/4 (0.00%) 

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Minoo Battiwalla, MD
Organization: Hematology Branch, NHLBI
Phone: 301 827 0939
EMail: battiwam@nhlbi.nih.gov
Layout table for additonal information
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 ( Other Identifier: National Heart Lung and Blood Institute )
First Submitted: February 9, 2007
First Posted: February 12, 2007
Results First Submitted: April 30, 2013
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014