TriangleNCT03246529 · OUTCOME
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of responders
- Interval / dispersion
- Not reported
- Time frame
- From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6
What was measured
Percentage of subjects mobilizing ≥6 × 10\^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo. Based on central laboratory data.
Analysis population: Full Analysis Set (FAS) for Part 1 (Part 1 of the study assessed the mobilization using local lab only), Intention-to-Treat (ITT) for Part 2
Groups in this outcome
BL-8040 + G-CSF Part 1
Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
BL-8040 + G-CSF Part 2
Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
Placebo + G-CSF Part 2
Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
| Group | Source count |
|---|---|
| BL-8040 + G-CSF Part 1 | 12 |
| BL-8040 + G-CSF Part 2 | 80 |
| Placebo + G-CSF Part 2 | 42 |
Reported measurements
Central Lab
| Group | Source count |
|---|---|
| BL-8040 + G-CSF Part 1 | 0 |
| BL-8040 + G-CSF Part 2 | 80 |
| Placebo + G-CSF Part 2 | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BL-8040 + G-CSF Part 2 | 70.0 | Not reported | Not reported | Not reported | Not reported |
| Placebo + G-CSF Part 2 | 14.3 | Not reported | Not reported | Not reported | Not reported |
Local Lab
| Group | Source count |
|---|---|
| BL-8040 + G-CSF Part 1 | 12 |
| BL-8040 + G-CSF Part 2 | 80 |
| Placebo + G-CSF Part 2 | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BL-8040 + G-CSF Part 1 | 91.7 | Not reported | Not reported | Not reported | Not reported |
| BL-8040 + G-CSF Part 2 | 92.5 | Not reported | Not reported | Not reported | Not reported |
| Placebo + G-CSF Part 2 | 26.2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Comment
- Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Comment
- Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG001
- value
- 70.0
- group Id
- OG002
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 42
- units
- Participants
- title
- Central Lab
- categories
- measurements
- group Id
- OG000
- value
- 91.7
- group Id
- OG001
- value
- 92.5
- group Id
- OG002
- value
- 26.2
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 42
- units
- Participants
- title
- Local Lab
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 42
- units
- Participants
- description
- Percentage of subjects mobilizing ≥6 × 10\^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo. Based on central laboratory data.
- groups
- description
- Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
- id
- OG000
- title
- BL-8040 + G-CSF Part 1
- description
- Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
- id
- OG001
- title
- BL-8040 + G-CSF Part 2
- description
- Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
- id
- OG002
- title
- Placebo + G-CSF Part 2
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS) for Part 1 (Part 1 of the study assessed the mobilization using local lab only), Intention-to-Treat (ITT) for Part 2
- reporting Status
- POSTED
- time Frame
- From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6
- title
- Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions
- type
- PRIMARY
- unit Of Measure
- Percentage of responders
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice