TriangleNCT02005471 · OUTCOME
Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by 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 3 years)
What was measured
Assessment of response was performed by the IRC 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. No new IRC data was generated post the primary analysis.
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 | 47.8 | Not reported | Not reported | Not reported | Not reported |
| Venetoclax + Rituximab 17p Del. Population | 19.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 47.8
- group Id
- OG001
- value
- 19.6
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 46
- units
- Participants
- description
- Assessment of response was performed by the IRC 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. No new IRC data was generated post the primary analysis.
- 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 3 years)
- title
- Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice