Trial · NCT00086580
Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients
NCT00086580, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2011-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients. Trials, record NCT00086580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients
- NCT number
- NCT00086580
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 335 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Interventions
- FluCAM [Fludara + Campath], fludarabine phosphate
- First posted
- 2004-07-08
- Last updated
- 2014-03-13
- Other registries' IDs
- eudract:2004-000149-39
- Results first posted
- 2011-08-11
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment | Up to 6 years | Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months. |
| Secondary | Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Up to 9 months | Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology. |
| Secondary | Kaplan-Meier Estimates of Overall Survival Time | Up to 6 years | Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months. |
| Secondary | Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP) | Up to 6 years | Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months. |
| Secondary | Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP) | Up to 6 years | Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months. |
| Secondary | Kaplan-Meier Estimates for Time to Alternative Therapy | Up to 6 years | Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months. |
| Secondary | Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline | Day 0 (baseline) | EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59). |
| Secondary | Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment | up to month 6 (end of treatment) | EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59). |
| Secondary | Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline | Day 0 (baseline) | The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual "thermometer" with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom. |
| Secondary | Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment | up to month 6 (end of treatment) | The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual "thermometer" with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment | Up to 6 years | Full analysis set | months | MEDIAN |
| SECONDARY | Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Up to 9 months | Full analysis set | participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Overall Survival Time | Up to 6 years | Full analysis set | months | MEDIAN |
| SECONDARY | Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP) | Up to 6 years | Full analysis set | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP) | Up to 6 years | Full analysis set of participants who achieved a complete response or a partial response as determined by the IRRP. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates for Time to Alternative Therapy | Up to 6 years | Full analysis set | months | MEDIAN |
| SECONDARY | Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline | Day 0 (baseline) | Full analysis dataset. Participants who provided valid answers on questionnaires are included. | units on a scale | MEAN |
| SECONDARY | Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment | up to month 6 (end of treatment) | Full analysis dataset. Participants who provided valid answers on questionnaires are included. | units on a scale | MEAN |
| SECONDARY | Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline | Day 0 (baseline) | Full analysis set. Participants who provided valid answers on questionnaires are included. | units on a scale | MEAN |
| SECONDARY | Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment | up to month 6 (end of treatment) | Full analysis set. Participants who provided valid answers on questionnaires are included. | units on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment | Combination Arm (FluCAM) | 23.65 | 95% Confidence Interval 19.180 to 28.360 | months | |
| Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment | Fludarabine Alone | 16.48 | 95% Confidence Interval 12.500 to 21.220 | months | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Combination Arm (FluCAM) | Overall Response (CR+PR) | 137 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Fludarabine Alone | Overall Response (CR+PR) | 126 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Combination Arm (FluCAM) | Complete Response (CR) | 21 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Fludarabine Alone | Complete Response (CR) | 7 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Combination Arm (FluCAM) | Partial Response (PR) | 116 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Fludarabine Alone | Partial Response (PR) | 119 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Combination Arm (FluCAM) | Progressive Disease (PD) | 6 | participants | |
| Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP) | Fludarabine Alone | Progressive Disease (PD) | 9 | participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Combination Arm (FluCAM) | 168 | |
| Treatment Period | STARTED | Fludarabine Alone | 167 | |
| Treatment Period | Safety Population | Combination Arm (FluCAM) | 164 | |
| Treatment Period | Safety Population | Fludarabine Alone | 165 | |
| Treatment Period | COMPLETED | Combination Arm (FluCAM) | 103 | |
| Treatment Period | COMPLETED | Fludarabine Alone | 107 | |
| Treatment Period | NOT COMPLETED | Combination Arm (FluCAM) | 65 | |
| Treatment Period | NOT COMPLETED | Fludarabine Alone | 60 | |
| Follow-up Period | STARTED | Combination Arm (FluCAM) | 141 | |
| Follow-up Period | STARTED | Fludarabine Alone | 137 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events928
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 | Anaemia | Blood and lymphatic system disorders | Combination Arm (FluCAM) | 36 | 164 | |
| other | Anaemia | Blood and lymphatic system disorders | Fludarabine Alone | 39 | 165 | |
| other | Autoimmune thrombocytopenia | Blood and lymphatic system disorders | Combination Arm (FluCAM) | 0 | 164 | |
| other | Autoimmune thrombocytopenia | Blood and lymphatic system disorders | Fludarabine Alone | 1 | 165 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Combination Arm (FluCAM) | 1 | 164 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Fludarabine Alone | 3 | 165 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Combination Arm (FluCAM) | 1 | 164 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Fludarabine Alone | 4 | 165 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | Combination Arm (FluCAM) | 3 | 164 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | Fludarabine Alone | 1 | 165 |
1 to 10 of 928Source ClinicalTrials.gov
See all 928 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Arm (FluCAM) | ||
| Total, all-cause mortality | Fludarabine Alone | ||
| Total, other adverse events | Combination Arm (FluCAM) | 160 | 164 |
| Total, other adverse events | Fludarabine Alone | 147 | 165 |
| Total, serious adverse events | Combination Arm (FluCAM) | 54 | 164 |
| Total, serious adverse events | Fludarabine Alone | 41 | 165 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21992852 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Combination Arm (FluCAM) vs Fludarabine Alone: Participants With Minimal Residual Disease (MRD) | Trial comparisons |
| Combination Arm (FluCAM) vs Fludarabine Alone: serious adverse events | 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/NCT00086580
GET https://conductscience.org/api/trials/v1/NCT00086580/results?page=2