TriangleNCT02005471 · OUTCOME
Percentage of Participants With MRD Negativity in Bone Marrow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
What was measured
MRD-negativity was defined as the presence of \<1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentages are rounded off.
Analysis population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
Groups in this outcome
Bendamustine + Rituximab Main Study
Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Venetoclax + Rituximab Main Study
Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
| Group | Source count |
|---|---|
| Bendamustine + Rituximab Main Study | 195 |
| Venetoclax + Rituximab Main Study | 194 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 1.0 | Not reported | 0.12 | 3.66 | Not reported |
| Venetoclax + Rituximab Main Study | 14.4 | Not reported | 9.81 | 20.18 | Not reported |
Source statistical analyses
- ci Lower Limit
- 7.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.82
- estimate Comment
- The 95% CI was computed using Anderson-Hauck method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Difference in MRD negative rates
- param Value
- 13.41
- statistical Method
- Chi-squared
- ci Lower Limit
- 3.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 69.35
- estimate Comment
- OR was estimated using logistic regression model. The 95% CI was computed using Wald test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 16.28
Complete source fields
- analyses
- ci Lower Limit
- 7.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.82
- estimate Comment
- The 95% CI was computed using Anderson-Hauck method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Difference in MRD negative rates
- param Value
- 13.41
- statistical Method
- Chi-squared
- ci Lower Limit
- 3.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 69.35
- estimate Comment
- OR was estimated using logistic regression model. The 95% CI was computed using Wald test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 16.28
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.12
- upper Limit
- 3.66
- value
- 1.0
- group Id
- OG001
- lower Limit
- 9.81
- upper Limit
- 20.18
- value
- 14.4
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 194
- units
- Participants
- description
- MRD-negativity was defined as the presence of \<1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentages are rounded off.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
- id
- OG000
- title
- Bendamustine + Rituximab Main Study
- description
- Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
- id
- OG001
- title
- Venetoclax + Rituximab Main Study
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
- title
- Percentage of Participants With MRD Negativity in Bone Marrow
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice