TriangleNCT00090051 · STUDY IN CONTEXT
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.
Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- trial label
- FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0000
- source section id
- NCT00090051-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
- endpoint definition
- Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
- time origin
- Mean observation time at time of analysis was approximately 26 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0005
- source section id
- NCT00090051-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
- endpoint definition
- Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
- time origin
- Mean observation time at time of analysis was approximately 26 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0001
- source section id
- NCT00090051-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
- time origin
- Mean observation time at time of analysis was approximately 26 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0002
- source section id
- NCT00090051-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Overall Survival (OS) Events
- endpoint definition
- Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
- time origin
- Mean observation time at time of analysis was approximately 26 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0003
- source section id
- NCT00090051-om-0003
- source outcome index
- 3
- endpoint
- Event-free Survival (EFS)
- endpoint definition
- Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.
- time origin
- Mean observation time at time of analysis was approximately 26 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0004
- source section id
- NCT00090051-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Event-free Survival (EFS) Events
- endpoint definition
- Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.
- time origin
- Mean observation time at time of analysis was approximately 26 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Fludarabine+Cyclophosphamide (FC)
- regimen
- 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.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- regimen
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Fludarabine+Cyclophosphamide (FC)
- regimen
- 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.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- regimen
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Fludarabine+Cyclophosphamide (FC)
- regimen
- 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.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- regimen
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Fludarabine+Cyclophosphamide (FC)
- regimen
- 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.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- regimen
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Fludarabine+Cyclophosphamide (FC)
- regimen
- 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.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- regimen
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Fludarabine+Cyclophosphamide (FC)
- regimen
- 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.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- regimen
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- analyzed count
- 276
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00090051-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- harm key
- EG000
- source section id
- NCT00090051-ae
- event group key
- EG000
- event group label
- Fludarabine+Cyclophosphamide (FC)
- serious affected
- 132
- serious at risk
- 272
- other affected
- 232
- other at risk
- 272
- frequency threshold
- 5
- collection period
- Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).
- event definition
- The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-lymphocytic-leukemia-recurrent-b07a4c4d
- nct id
- NCT00090051
- harm key
- EG001
- source section id
- NCT00090051-ae
- event group key
- EG001
- event group label
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- serious affected
- 138
- serious at risk
- 274
- other affected
- 251
- other at risk
- 274
- frequency threshold
- 5
- collection period
- Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).
- event definition
- The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice