Trial · NCT01477749
Sipuleucel-T Manufacturing Demonstration Study
NCT01477749, Phase 2, Completed, Dendreon; results first posted 2015-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sipuleucel-T Manufacturing Demonstration Study. Trials, record NCT01477749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01477749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sipuleucel-T Manufacturing Demonstration Study
- NCT number
- NCT01477749
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Cancer of Prostate, Cancer of the Prostate, Neoplasms, Prostate, Neoplasms, Prostatic, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer
- Interventions
- sipuleucel-T
- First posted
- 2011-11-23
- Last updated
- 2015-12-09
- Other registries' IDs
- eudract:2011-001192-39
- Results first posted
- 2015-12-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative CD54+ Cell Count | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | Descriptive summarization of the cumulative sum of CD54+ counts across infusions. Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3 |
| Primary | Cumulative CD54 Upregulation | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3. |
| Primary | Cumulative Total Nucleated Cell (TNC) Count | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | Descriptive summarization of the cumulative sum of TNC counts across infusions |
| Primary | Product Viability (Percentage) | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative CD54+ Cell Count | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | 10^9 cells/mL | MEAN | |
| PRIMARY | Cumulative CD54 Upregulation | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | Ratio | MEAN | |
| PRIMARY | Cumulative Total Nucleated Cell (TNC) Count | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | 10^9 cells/mL | MEAN | |
| PRIMARY | Product Viability (Percentage) | Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) | Percentage of PBMC that are live | MEAN |
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 |
|---|---|---|---|---|---|
| Cumulative CD54+ Cell Count | Sipuleucel-T | 1.58 | Standard Error .10 | 10^9 cells/mL | |
| Cumulative CD54 Upregulation | Sipuleucel-T | 34.10 | Standard Error 1.24 | Ratio | |
| Cumulative Total Nucleated Cell (TNC) Count | Sipuleucel-T | 12.54 | Standard Error .74 | 10^9 cells/mL | |
| Product Viability (Percentage) | Sipuleucel-T | 96.75 | Full Range 90.40 to 99.53 | Percentage of PBMC that are live |
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 | Sipuleucel-T | 47 | |
| Overall Study | COMPLETED | Sipuleucel-T | 43 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T | 4 |
Source ClinicalTrials.gov
Adverse events21
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 | FATIGUE | General disorders | Sipuleucel-T | 14 | 47 | |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | Sipuleucel-T | 11 | 47 | |
| other | CHILLS | General disorders | Sipuleucel-T | 10 | 47 | |
| other | DIZZINESS | Nervous system disorders | Sipuleucel-T | 5 | 47 | |
| other | NAUSEA | Gastrointestinal disorders | Sipuleucel-T | 5 | 47 | |
| other | MYALGIA | Musculoskeletal and connective tissue disorders | Sipuleucel-T | 4 | 47 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Sipuleucel-T | 3 | 47 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Sipuleucel-T | 3 | 47 | |
| other | BONE PAIN | Musculoskeletal and connective tissue disorders | Sipuleucel-T | 3 | 47 | |
| other | CITRATE TOXICITY | Injury, poisoning and procedural complications | Sipuleucel-T | 3 | 47 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T | ||
| Total, other adverse events | Sipuleucel-T | 40 | 47 |
| Total, serious adverse events | Sipuleucel-T | 3 | 47 |
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/NCT01477749
GET https://conductscience.org/api/trials/v1/NCT01477749/events?page=2