TriangleNCT00438880 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 1 year from treatment start date
What was measured
The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
Analysis population: Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.
Groups in this outcome
Phase I
Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
Phase II
Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
| Group | Source count |
|---|---|
| Phase I | 0 |
| Phase II | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II | 1.57 | Not reported | 1.22 | 3.42 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 1.22
- upper Limit
- 3.42
- value
- 1.57
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
- id
- OG000
- title
- Phase I
- description
- Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
- id
- OG001
- title
- Phase II
- param Type
- MEDIAN
- population Description
- Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 1 year from treatment start date
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice