TriangleNCT02005471 · OUTCOME
Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test
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
- Not reported
- Time frame
- Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
What was measured
Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. Percentages are rounded off.
Analysis population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
Groups in this outcome
Bendamustine + Rituximab 17p Del. Population
Participants received bendamustine at a dose of 70 mg/m\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.
Venetoclax + Rituximab 17p Del. Population
Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.
| Group | Source count |
|---|---|
| Bendamustine + Rituximab 17p Del. Population | 46 |
| Venetoclax + Rituximab 17p Del. Population | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab 17p Del. Population | 80.4 | Not reported | Not reported | Not reported | Not reported |
| Venetoclax + Rituximab 17p Del. Population | 80.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 80.4
- group Id
- OG001
- value
- 80.4
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 46
- units
- Participants
- description
- Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. Percentages are rounded off.
- groups
- description
- Participants received bendamustine at a dose of 70 mg/m\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.
- id
- OG000
- title
- Bendamustine + Rituximab 17p Del. Population
- description
- Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.
- id
- OG001
- title
- Venetoclax + Rituximab 17p Del. Population
- param Type
- NUMBER
- population Description
- Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
- reporting Status
- POSTED
- time Frame
- Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
- title
- Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice