Trial · NCT00281918
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
NCT00281918, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia. Trials, record NCT00281918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00281918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
- NCT number
- NCT00281918
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 817 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Leukemia
- Interventions
- Rituximab, Cyclophosphamide, Fludarabine Phosphate
- First posted
- 2006-01-25
- Last updated
- 2013-09-19
- Results first posted
- 2011-03-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Median observation time at time of analysis was approximately 21 months | Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. |
| Primary | Final Analysis: Time to Progression-free Survival Event | Median observation time was approximately 66.4 months | Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. |
| Secondary | Event-free Survival (EFS) | Median observation time at time of analysis was approximately 21 months | Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause. |
| Secondary | Overall Survival (OS) | Median observation time at time of analysis was approximately 21 months | Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached. |
| Secondary | Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). | Median observation time at time of analysis was approximately 21 months | 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. |
| Secondary | Final Analysis: Time to Overall Survival Event | Median observation time was approximately 66.4 months | Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. |
| Secondary | Final Analysis: Time to Event-free Survival Event | Median observation time was approximately 66.4 months | Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause. |
| Secondary | Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) | Median observation time was approximately 66.4 months | 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 |
| Secondary | Final Analysis: Duration of Response | Median observation time was approximately 66.4 months | Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause. |
| Secondary | Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response | Median observation time was approximately 66.4 months | 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. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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) | Median observation time at time of analysis was approximately 21 months | The Intent-to-treat (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. | Days | MEDIAN |
| SECONDARY | Event-free Survival (EFS) | Median observation time at time of analysis was approximately 21 months | 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. | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Median observation time at time of analysis was approximately 21 months | 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. | Days | NUMBER |
| SECONDARY | Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). | Median observation time at time of analysis was approximately 21 months | 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. | Days to an event | NUMBER |
| PRIMARY | Final Analysis: Time to Progression-free Survival Event | Median observation time was approximately 66.4 months | Participants from the Intent-to-treat population, that included all randomized participants, with PFS events. | Days | MEDIAN |
| SECONDARY | Final Analysis: Time to Overall Survival Event | Median observation time was approximately 66.4 months | Participants from the Intent-to-treat population, that included all randomized participants who died. | Days | MEDIAN |
| SECONDARY | Final Analysis: Time to Event-free Survival Event | Median observation time was approximately 66.4 months | Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death. | Days | MEDIAN |
| SECONDARY | Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) | Median observation time was approximately 66.4 months | Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death). | Days | MEDIAN |
| SECONDARY | Final Analysis: Duration of Response | Median observation time was approximately 66.4 months | Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause). | Days | MEDIAN |
| SECONDARY | Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response | Median observation time was approximately 66.4 months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group26
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) | Fludarabine+Cyclophosphamide (FC) | 981.0 | Full Range 1 to 1343 | Days | |
| Progression-free Survival (PFS) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1212.0 | Full Range 1 to 1372 | Days | |
| Event-free Survival (EFS) | Fludarabine+Cyclophosphamide (FC) | 947.0 | Full Range 1 to 1343 | Days | |
| Event-free Survival (EFS) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 1212.0 | Full Range 1 to 1372 | Days | |
| Overall Survival (OS) | Fludarabine+Cyclophosphamide (FC) | Minimum number of days to an event | 5 | 83 to 90 | Days |
| Overall Survival (OS) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | Minimum number of days to an event | 4 | 89 to 95 | Days |
| Overall Survival (OS) | Fludarabine+Cyclophosphamide (FC) | Maximum number of days to an event | 1373 | Days | |
| Overall Survival (OS) | Fludarabine+Cyclophosphamide+Rituximab (FCR) | Maximum number of days to an event | 1372 | Days | |
| Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). | Fludarabine+Cyclophosphamide (FC) | Minimum number of days to an event | 84 | 0 to 0 | Days to an event |
| Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). | Fludarabine+Cyclophosphamide+Rituximab (FCR) | Minimum number of days to an event | 91 | 939 to 9999 | Days to an event |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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) | 409 | |
| Overall Study | STARTED | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 408 | |
| Overall Study | Safety Population; Received Study Drug | Fludarabine+Cyclophosphamide (FC) | 398 | |
| Overall Study | Safety Population; Received Study Drug | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 402 | |
| Overall Study | COMPLETED | Fludarabine+Cyclophosphamide (FC) | 267 | |
| Overall Study | COMPLETED | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 300 | |
| Overall Study | NOT COMPLETED | Fludarabine+Cyclophosphamide (FC) | 142 | |
| Overall Study | NOT COMPLETED | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 108 |
Source ClinicalTrials.gov
Adverse events452
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) | 71 | 398 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 116 | 402 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 45 | 398 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 88 | 402 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide (FC) | 35 | 398 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 21 | 402 | |
| serious | Pneumonia | Infections and infestations | Fludarabine+Cyclophosphamide (FC) | 21 | 398 | |
| serious | Pneumonia | Infections and infestations | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 18 | 402 | |
| serious | Herpes Zoster | Infections and infestations | Fludarabine+Cyclophosphamide (FC) | 6 | 398 | |
| serious | Herpes Zoster | Infections and infestations | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 8 | 402 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 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) | 122 | 398 |
| Total, other adverse events | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 185 | 402 |
| Total, serious adverse events | Fludarabine+Cyclophosphamide (FC) | 164 | 398 |
| Total, serious adverse events | Fludarabine+Cyclophosphamide+Rituximab (FCR) | 186 | 402 |
Source ClinicalTrials.gov
Papers11
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/NCT00281918
GET https://conductscience.org/api/trials/v1/NCT00281918/results?page=2