Comparison · NCT00086580-6f12bf07
Combination Arm (FluCAM) vs Fludarabine Alone: Participants With Minimal Residual Disease (MRD)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Combination Arm (FluCAM) vs Fludarabine Alone: Participants With Minimal Residual Disease (MRD). Trial comparisons, record NCT00086580-6f12bf07. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00086580-6f12bf07
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0357 | 0.0165 | 0.0757 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0225 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0357 | 0.00612 | 0.0757 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Combination Arm (FluCAM) than on Fludarabine Alone | 28 | 13.2 | 163 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Combination Arm (FluCAM) | Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m\^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle. | 6 | 168 | OG000 |
| Group 2 | Fludarabine Alone | Participants received fludarabine monotherapy 25 mg/m\^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles. | 0 | 167 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Participants With Minimal Residual Disease (MRD)
- Description
MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome.
- Time frame
- up to 9 months
- Population
- Full analysis set
Source ClinicalTrials.gov
Trial
- Title
- Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients
- NCT number
- NCT00086580
- Phases
- PHASE3
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Interventions
- FluCAM [Fludara + Campath], fludarabine phosphate
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2011-08-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00086580?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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