Trial · NCT00090051
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
NCT00090051, Phase 3, Completed, Hoffmann-La Roche; results first posted 2012-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients. Trials, record NCT00090051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090051
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
- NCT number
- NCT00090051
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 552 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Rituximab, Fludarabine Phosphate, Cyclophosphamide
- First posted
- 2004-08-25
- Last updated
- 2017-08-01
- Results first posted
- 2012-01-23
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Mean observation time at time of analysis was approximately 26 months | 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. |
| Primary | Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC) | Mean observation time at time of analysis was approximately 26 months | 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. |
| Primary | Final Analysis: Time to Progression-Free Survival Event | Median observation time was approximately 5 years | Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first. |
| Secondary | Overall Survival (OS) | Mean observation time at time of analysis was approximately 26 months | 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. |
| Secondary | Number of Participants With Overall Survival (OS) Events | Mean observation time at time of analysis was approximately 26 months | 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. |
| Secondary | Event-free Survival (EFS) | Mean observation time at time of analysis was approximately 26 months | 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. |
| Secondary | Number of Participants With Event-free Survival (EFS) Events | Mean observation time at time of analysis was approximately 26 months | 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. |
| Secondary | Disease-free Survival (DFS) | Mean observation time at time of analysis was approximately 26 months | Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date. |
| Secondary | Number of Participants With Disease-free Survival (DFS) Events | Mean observation time at time of analysis was approximately 26 months | Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date. |
| Secondary | Final Analysis: Time to Overall Survival Event | Median observation time was approximately 5 years | Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. | Days | MEDIAN |
| SECONDARY | Number of Participants With Overall Survival (OS) Events | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. | participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. | Days | MEDIAN |
| SECONDARY | Number of Participants With Event-free Survival (EFS) Events | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. | participants | NUMBER |
| PRIMARY | Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC) | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. | participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response. | Days | MEDIAN |
| SECONDARY | Number of Participants With Disease-free Survival (DFS) Events | Mean observation time at time of analysis was approximately 26 months | Intent-to-treat (ITT) population with a Best Overall Response of Complete Response. | participants | NUMBER |
| PRIMARY | Final Analysis: Time to Progression-Free Survival Event | Median observation time was approximately 5 years | Participants from the Intent-to-treat population, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact. | Days | MEDIAN |
| SECONDARY | Final Analysis: Time to Overall Survival Event | Median observation time was approximately 5 years | The analysis included only those participants from the Intent-to-treat population,all randomized participants, who died. Participants who had not died at the time of the final analysis were censored at the date of the last contact. | Days | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Fludarabine+Cyclophosphamide (FC) | 660 | 95% Confidence Interval 556 to 735 | Days | |
| Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 813 | 95% Confidence Interval 670 to 947 | Days | |
| Overall Survival (OS) | Fludarabine+Cyclophosphamide (FC) | 1580 | 95% Confidence Interval 1408 to NA | Days | |
| Overall Survival (OS) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | NA | 95% Confidence Interval 1552 to NA | Days | |
| Number of Participants With Overall Survival (OS) Events | Fludarabine+Cyclophosphamide (FC) | Patients with event | 68 | participants | |
| Number of Participants With Overall Survival (OS) Events | Fludarabine+Cyclophosphamide+Rituximab (FCR) | Patients with event | 62 | participants | |
| Number of Participants With Overall Survival (OS) Events | Fludarabine+Cyclophosphamide (FC) | Patients without events | 208 | participants | |
| Number of Participants With Overall Survival (OS) Events | Fludarabine+Cyclophosphamide+Rituximab (FCR) | Patients without events | 214 | participants | |
| Event-free Survival (EFS) | Fludarabine+Cyclophosphamide (FC) | 586 | 95% Confidence Interval 545 to 731 | Days | |
| Event-free Survival (EFS) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 874 | 95% Confidence Interval 756 to 1187 | Days |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fludarabine+Cyclophosphamide (FC) | 276 | |
| Overall Study | STARTED | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 276 | |
| Overall Study | Safety Population; Received Study Drug | Fludarabine+Cyclophosphamide (FC) | 272 | |
| Overall Study | Safety Population; Received Study Drug | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 274 | |
| Overall Study | COMPLETED | Fludarabine+Cyclophosphamide (FC) | 167 | |
| Overall Study | COMPLETED | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 181 | |
| Overall Study | NOT COMPLETED | Fludarabine+Cyclophosphamide (FC) | 109 | |
| Overall Study | NOT COMPLETED | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 95 |
Source ClinicalTrials.gov
Adverse events442
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 110 | 272 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 120 | 274 | |
| other | Anaemia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 47 | 272 | |
| other | Anaemia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 55 | 274 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 33 | 272 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 36 | 274 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 12 | 272 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 18 | 274 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 14 | 272 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 16 | 274 |
1 to 10 of 442Source ClinicalTrials.gov
See all 442 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fludarabine+Cyclophosphamide (FC) | ||
| Total, all-cause mortality | Fludarabine+Cyclophosphamide+Rituximab (FCR) | ||
| Total, other adverse events | Fludarabine+Cyclophosphamide (FC) | 232 | 272 |
| Total, other adverse events | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 251 | 274 |
| Total, serious adverse events | Fludarabine+Cyclophosphamide (FC) | 132 | 272 |
| Total, serious adverse events | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 138 | 274 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fludarabine+Cyclophosphamide (FC) vs Fludarabine+Cyclophosphamide+Rituximab (FCR): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00090051
GET https://conductscience.org/api/trials/v1/NCT00090051/results?page=2