NCT02339922 · OUTCOME
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years
What was measured
ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.
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
| 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL | 0 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for FL | 13 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for MZL | 2 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Ixazomib Citrate, Rituximab) for MCL | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived.
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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