TriangleNCT00281918 · OUTCOME
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Days to an event
- Interval / dispersion
- Not reported
- Time frame
- Median observation time at time of analysis was approximately 21 months
What was measured
CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.
Analysis population: The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.
Groups in this outcome
Fludarabine+Cyclophosphamide (FC)
Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
| Group | Source count |
|---|---|
| Fludarabine+Cyclophosphamide (FC) | 407 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 403 |
Reported measurements
Minimum number of days to an event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fludarabine+Cyclophosphamide (FC) | 84 | Not reported | 0 | 0 | Not reported |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 91 | Not reported | 939 | 9999 | Not reported |
Maximum number of days to an event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fludarabine+Cyclophosphamide (FC) | 1164 | Not reported | Not reported | Not reported | Not reported |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1226 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7882
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7882
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 84
- group Id
- OG001
- lower Limit
- 939
- upper Limit
- 9999
- value
- 91
- title
- Minimum number of days to an event
- categories
- measurements
- group Id
- OG000
- value
- 1164
- group Id
- OG001
- value
- 1226
- title
- Maximum number of days to an event
- denoms
- counts
- group Id
- OG000
- value
- 407
- group Id
- OG001
- value
- 403
- units
- Participants
- description
- CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.
- groups
- description
- Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
- id
- OG000
- title
- Fludarabine+Cyclophosphamide (FC)
- description
- Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
- id
- OG001
- title
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- param Type
- NUMBER
- population Description
- The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.
- reporting Status
- POSTED
- time Frame
- Median observation time at time of analysis was approximately 21 months
- title
- Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
- type
- SECONDARY
- unit Of Measure
- Days to an event
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Preserved source evidence · Not medical advice