Trial · NCT00466726
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
NCT00466726, Phase 2, Completed, Gruppo Italiano Malattie EMatologiche dell'Adulto; results first posted 2018-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia. Trials, record NCT00466726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00466726
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
- NCT number
- NCT00466726
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Conditions
- Leukemia
- Interventions
- bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine, sargramostim
- First posted
- 2007-04-27
- Last updated
- 2018-08-28
- Other registries' IDs
- eudract:2006-006189-40
- Results first posted
- 2018-08-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level | At 6 and 9 months | Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination) |
| Secondary | Number of Patients With Undetectable Transcript at Any Time After Immunization | Up to 6 months | |
| Secondary | Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations | At 9 months | A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level | At 6 and 9 months | participants | NUMBER | |
| SECONDARY | Number of Patients With Undetectable Transcript at Any Time After Immunization | Up to 6 months | participants | NUMBER | |
| SECONDARY | Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations | At 9 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level | Chronic Myeloid Leukemia (CML) Patients | 50% reduction at 6 months | 22 | participants | |
| Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level | Chronic Myeloid Leukemia (CML) Patients | 50% reduction at 9 months | 14 | participants | |
| Number of Patients With Undetectable Transcript at Any Time After Immunization | Chronic Myeloid Leukemia (CML) Patients | 14 | participants | ||
| Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations | Chronic Myeloid Leukemia (CML) Patients | 29 | 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 | Chronic Myeloid Leukemia (CML) Patients | 57 | |
| Overall Study | COMPLETED | Chronic Myeloid Leukemia (CML) Patients | 43 | |
| Overall Study | NOT COMPLETED | Chronic Myeloid Leukemia (CML) Patients | 14 |
Source ClinicalTrials.gov
Adverse events1
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 | Mild fever | General disorders | Chronic Myeloid Leukemia (CML) Patients | 4 | 43 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chronic Myeloid Leukemia (CML) Patients | ||
| Total, other adverse events | Chronic Myeloid Leukemia (CML) Patients | 4 | 43 |
| Total, serious adverse events | Chronic Myeloid Leukemia (CML) Patients | 0 | 43 |
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/NCT00466726
GET https://conductscience.org/api/trials/v1/NCT00466726/registered