TriangleNCT01094548 · OUTCOME
Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of randomization up to Week 104
What was measured
The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \[IFN\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \[PBMC\]) with ratio to background \>=2, and ratio of background-corrected value to baseline \>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\[t\]=1), upon fulfilling the following criteria: Yt =\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).
Analysis population: Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
Groups in this outcome
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.
| Group | Source count |
|---|---|
| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 17 |
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 8 | Not reported | Not reported | Not reported | Not reported |
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 7 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 1.0000
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 1.0000
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \[IFN\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \[PBMC\]) with ratio to background \>=2, and ratio of background-corrected value to baseline \>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\[t\]=1), upon fulfilling the following criteria: Yt =\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).
- groups
- description
- Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.
- id
- OG000
- title
- Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
- description
- Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.
- id
- OG001
- title
- Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
- param Type
- NUMBER
- population Description
- Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
- reporting Status
- POSTED
- time Frame
- From the date of randomization up to Week 104
- title
- Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice