NCT02339922 · OUTCOME
Time to Next Therapy (TNT)
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 of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years
What was measured
Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact.
Analysis population: No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.
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 | 2 |
| Treatment (Ixazomib Citrate, Rituximab) for FL | 21 |
| Treatment (Ixazomib Citrate, Rituximab) for MZL | 6 |
| Treatment (Ixazomib Citrate, Rituximab) for MCL | 4 |
| Treatment (Ixazomib Citrate, Rituximab) for WM/LPL | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL | 49 | Not reported | 38 | 60 | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for FL | 30.3 | Not reported | 1 | 60 | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for MZL | 30.8 | Not reported | 0 | 60 | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for MCL | 23.5 | Not reported | 0 | 60 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38
- upper Limit
- 60
- value
- 49
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 60
- value
- 30.3
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 60
- value
- 30.8
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 60
- value
- 23.5
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact.
- 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 Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled.
- reporting Status
- POSTED
- time Frame
- From the time of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years
- title
- Time to Next Therapy (TNT)
- type
- SECONDARY
- unit Of Measure
- months
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