TriangleNCT00811733 · OUTCOME
Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- From baseline up to approximately 5 years
What was measured
Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node \>=1.5 centimeters on any axis. Progression for PR/MR is either a \>=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.
Analysis population: ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study.
Groups in this outcome
300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5
Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5
Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
| Group | Source count |
|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 7 |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 15 |
| Group | Source count |
|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 5 |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5 | 449.0 | Not reported | 275.0 | NA | There were too few events (disease progression or death) to estimate the third quartile. |
| 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5 | 455.0 | Not reported | 337.0 | 1016.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- There were too few events (disease progression or death) to estimate the third quartile.
- group Id
- OG000
- lower Limit
- 275.0
- upper Limit
- NA
- value
- 449.0
- group Id
- OG001
- lower Limit
- 337.0
- upper Limit
- 1016.0
- value
- 455.0
- denom Units Selected
- events
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 15
- units
- Participants
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 9
- units
- events
- description
- Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node \>=1.5 centimeters on any axis. Progression for PR/MR is either a \>=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
- id
- OG000
- title
- 300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5
- description
- Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
- id
- OG001
- title
- 300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5
- param Type
- MEDIAN
- population Description
- ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study.
- reporting Status
- POSTED
- time Frame
- From baseline up to approximately 5 years
- title
- Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator
- type
- SECONDARY
- type Units Analyzed
- events
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice