NCT02339922 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years
What was measured
DOR will be calculated to determine durability. Non-responders will be excluded from the analysis of DOR. Kaplan Meier methodology will be used to estimate event-free curves.
Analysis population: No patients with CLL/SLL or WM/LPL met criteria to be included in DOR.
Groups in this outcome
Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL
Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Treatment (Ixazomib Citrate, Rituximab) for FL
Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Treatment (Ixazomib Citrate, Rituximab) for MZL
Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Treatment (Ixazomib Citrate, Rituximab) for MCL
Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
Treatment (Ixazomib Citrate, Rituximab) for WM/LPL
Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
| Group | Source count |
|---|---|
| Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL | 0 |
| Treatment (Ixazomib Citrate, Rituximab) for FL | 13 |
| Treatment (Ixazomib Citrate, Rituximab) for MZL | 2 |
| Treatment (Ixazomib Citrate, Rituximab) for MCL | 2 |
| Treatment (Ixazomib Citrate, Rituximab) for WM/LPL | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Ixazomib Citrate, Rituximab) for FL | 42 | Not reported | 1 | 60 | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for MZL | 35 | Not reported | 10 | 60 | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for MCL | 60 | Not reported | 60 | 60 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 60
- value
- 42
- group Id
- OG002
- lower Limit
- 10
- upper Limit
- 60
- value
- 35
- group Id
- OG003
- lower Limit
- 60
- upper Limit
- 60
- value
- 60
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- DOR will be calculated to determine durability. Non-responders will be excluded from the analysis of DOR. Kaplan Meier methodology will be used to estimate event-free curves.
- dispersion Type
- Full Range
- groups
- description
- Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
- id
- OG000
- title
- Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL
- description
- Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
- id
- OG001
- title
- Treatment (Ixazomib Citrate, Rituximab) for FL
- description
- Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
- id
- OG002
- title
- Treatment (Ixazomib Citrate, Rituximab) for MZL
- description
- Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
- id
- OG003
- title
- Treatment (Ixazomib Citrate, Rituximab) for MCL
- description
- Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity. Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Rituximab: Given IV
- id
- OG004
- title
- Treatment (Ixazomib Citrate, Rituximab) for WM/LPL
- param Type
- MEAN
- population Description
- No patients with CLL/SLL or WM/LPL met criteria to be included in DOR.
- reporting Status
- POSTED
- time Frame
- From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice
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