Trial Outcomes & Findings for Sipuleucel-T Manufacturing Demonstration Study (NCT NCT01477749)
NCT ID: NCT01477749
Last Updated: 2015-12-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
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)
Results posted on
2015-12-09
Participant Flow
Participant milestones
| Measure |
Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Sipuleucel-T Manufacturing Demonstration Study
Baseline characteristics by cohort
| Measure |
Sipuleucel-T
n=47 Participants
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Sipuleucel-T
n=47 Participants
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Cumulative CD54+ Cell Count
|
1.58 10^9 cells/mL
Standard Error .10
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sipuleucel-T
n=47 Participants
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Cumulative CD54 Upregulation
|
34.10 Ratio
Standard Error 1.24
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Sipuleucel-T
n=47 Participants
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Cumulative Total Nucleated Cell (TNC) Count
|
12.54 10^9 cells/mL
Standard Error .74
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sipuleucel-T
n=47 Participants
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
Product Viability (Percentage)
|
96.75 Percentage of PBMC that are live
Interval 90.4 to 99.53
|
Adverse Events
Sipuleucel-T
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sipuleucel-T
n=47 participants at risk
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
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|---|---|
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Renal and urinary disorders
CALCULUS URINARY
|
2.1%
1/47
|
|
General disorders
Fatigue
|
2.1%
1/47
|
|
Injury, poisoning and procedural complications
GASTROENTERITIS RADIATION
|
2.1%
1/47
|
|
General disorders
PAIN
|
2.1%
1/47
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
2.1%
1/47
|
Other adverse events
| Measure |
Sipuleucel-T
n=47 participants at risk
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
|
|---|---|
|
General disorders
FATIGUE
|
29.8%
14/47
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
23.4%
11/47
|
|
General disorders
CHILLS
|
21.3%
10/47
|
|
Nervous system disorders
DIZZINESS
|
10.6%
5/47
|
|
Gastrointestinal disorders
NAUSEA
|
10.6%
5/47
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
8.5%
4/47
|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.4%
3/47
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.4%
3/47
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
6.4%
3/47
|
|
Injury, poisoning and procedural complications
CITRATE TOXICITY
|
6.4%
3/47
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.4%
3/47
|
|
Vascular disorders
HYPERTENSION
|
6.4%
3/47
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.4%
3/47
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
3/47
|
|
General disorders
PAIN
|
6.4%
3/47
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.4%
3/47
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the study will be coordinated by Dendreon in communication with institutions contributing patients to the study.
- Publication restrictions are in place
Restriction type: OTHER