Trial Outcomes & Findings for PR1 Vaccination in Myelodysplastic Syndrome (MDS) (NCT NCT00893997)
NCT ID: NCT00893997
Last Updated: 2012-07-16
Results Overview
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.
TERMINATED
PHASE2
12 participants
29 weeks
2012-07-16
Participant Flow
Recruitment Period: 01/09/07 through 03/24/08. All participants recruited at UT MD Anderson Cancer Center.
Twelve patients were registered, two patients did not receive drug and were not included in the study group therefore ten patients were evaluable.
Participant milestones
| Measure |
PR-1 Vaccine
4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PR1 Vaccination in Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
PR-1 Vaccine
n=10 Participants
4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
|
|---|---|
|
Age Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 29 weeksPopulation: Analysis on patients treated; study terminated early.
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.
Outcome measures
| Measure |
PR-1 Vaccine
n=10 Participants
4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
|
|---|---|
|
Patient Immunologic Response
Immunological Response
|
3 participants
|
|
Patient Immunologic Response
No Immunological Response
|
7 participants
|
PRIMARY outcome
Timeframe: At 29 weeksPopulation: Analysis on patients treated; study terminated early.
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.
Outcome measures
| Measure |
PR-1 Vaccine
n=10 Participants
4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
|
|---|---|
|
Number of Patients With Clinical Response
Complete Response
|
0 participants
|
|
Number of Patients With Clinical Response
Hematological Improvement
|
1 participants
|
|
Number of Patients With Clinical Response
No Clinical Response
|
9 participants
|
Adverse Events
PR-1 Vaccine
Serious adverse events
| Measure |
PR-1 Vaccine
n=10 participants at risk
4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
|
|---|---|
|
General disorders
Allergic Reaction
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
Other adverse events
| Measure |
PR-1 Vaccine
n=10 participants at risk
4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
|
|---|---|
|
General disorders
Injection site reaction
|
40.0%
4/10 • Number of events 5 • 1 year and 11 months
|
|
General disorders
Allergic reaction
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • 1 year and 11 months
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
|
General disorders
Bone pain
|
20.0%
2/10 • Number of events 2 • 1 year and 11 months
|
|
General disorders
Chill
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
|
Skin and subcutaneous tissue disorders
Puritis
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
|
Gastrointestinal disorders
Mucositis
|
10.0%
1/10 • Number of events 1 • 1 year and 11 months
|
Additional Information
Guillermo Garcia-Manero, MD / Associate Professor
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place