Trial · NCT00893997
PR1 Vaccination in Myelodysplastic Syndrome (MDS)
NCT00893997, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2011-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PR1 Vaccination in Myelodysplastic Syndrome (MDS). Trials, record NCT00893997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00893997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PR1 Vaccination in Myelodysplastic Syndrome (MDS)
- NCT number
- NCT00893997
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia, Myelodysplastic Syndrome
- Interventions
- PR-1 vaccine
- First posted
- 2009-05-06
- Last updated
- 2012-07-16
- Results first posted
- 2011-04-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Immunologic Response | 29 weeks | 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. |
| Primary | Number of Patients With Clinical Response | At 29 weeks | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Immunologic Response | 29 weeks | Analysis on patients treated; study terminated early. | participants | NUMBER |
| PRIMARY | Number of Patients With Clinical Response | At 29 weeks | Analysis on patients treated; study terminated early. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Immunologic Response | PR-1 Vaccine | Immunological Response | 3 | participants | |
| Patient Immunologic Response | PR-1 Vaccine | No Immunological Response | 7 | participants | |
| Number of Patients With Clinical Response | PR-1 Vaccine | Complete Response | 0 | participants | |
| Number of Patients With Clinical Response | PR-1 Vaccine | Hematological Improvement | 1 | participants | |
| Number of Patients With Clinical Response | PR-1 Vaccine | No Clinical Response | 9 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PR-1 Vaccine | 10 | |
| Overall Study | COMPLETED | PR-1 Vaccine | 10 | |
| Overall Study | NOT COMPLETED | PR-1 Vaccine | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | PR-1 Vaccine | 4 | 10 | 5 |
| other | Allergic reaction | General disorders | PR-1 Vaccine | 1 | 10 | 1 |
| other | Fatigue | General disorders | PR-1 Vaccine | 2 | 10 | 2 |
| other | Nausea | Gastrointestinal disorders | PR-1 Vaccine | 1 | 10 | 1 |
| other | Vomiting | Gastrointestinal disorders | PR-1 Vaccine | 1 | 10 | 1 |
| other | Bone pain | General disorders | PR-1 Vaccine | 2 | 10 | 2 |
| other | Chill | General disorders | PR-1 Vaccine | 1 | 10 | 1 |
| other | Puritis | Skin and subcutaneous tissue disorders | PR-1 Vaccine | 1 | 10 | 1 |
| other | Mucositis | Gastrointestinal disorders | PR-1 Vaccine | 1 | 10 | 1 |
| serious | Allergic Reaction | General disorders | PR-1 Vaccine | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PR-1 Vaccine | ||
| Total, other adverse events | PR-1 Vaccine | 6 | 10 |
| Total, serious adverse events | PR-1 Vaccine | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00893997
GET https://conductscience.org/api/trials/v1/NCT00893997/registered