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CAM307

A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia

Phase 3N = 297NCT00046683

Population
Previously untreated patients with progressive B-cell chronic lymphocytic leukemia requiring treatment.
Design
Randomised comparison of intravenous alemtuzumab (30 mg three times per week for up to 12 weeks) with chlorambucil (40 mg/m2 every 28 days for up to 12 months) as first-line treatment; open-label per the registry record. Primary endpoint PFS. ClinicalTrials.gov (organisation study ID CAM307) lists 284 as the planned/enrolled number, against 297 randomised in the paper (the paper's number is used).
Primary endpoint
PFS
Arms
  • Alemtuzumab (experimental, n = 149): Intravenous alemtuzumab 30 mg three times per week, up to 12 weeks
  • Chlorambucil (control, n = 148): Chlorambucil 40 mg/m2 every 28 days, up to 12 months
People
Hillmen P
PFSHR 0.58Δ ORR+28 pointsΔ CR rate+22 points
Show the numbers
Results reported for CAM307
EndpointAnalysisAlemtuzumabChlorambucilEffect
PFSRandomised patients (297; analysis population not stated in the abstract)primaryHillmen 2007——HR 0.58P=0.0001Hazard ratio without a confidence interval in the abstract; medians not given in the abstract. Median time to alternative treatment 23.3 vs 14.7 months with chlorambucil (HR 0.54; P=.0001).
ORRRandomised patients (297; analysis population not stated in the abstract)primaryHillmen 200783%55%P<0.0001
CR rateRandomised patients (297; analysis population not stated in the abstract)primaryHillmen 200724%2%P<0.0001Minimal residual disease was eliminated in 11 of 36 complete responders to alemtuzumab and in none with chlorambucil.
Results reported for CAM307
EndpointAnalysisAlemtuzumabChlorambucilEffect
PFSRandomised patients (297; analysis population not stated in the abstract)primaryHillmen 2007——HR 0.58P=0.0001Hazard ratio without a confidence interval in the abstract; medians not given in the abstract. Median time to alternative treatment 23.3 vs 14.7 months with chlorambucil (HR 0.54; P=.0001).
ORRRandomised patients (297; analysis population not stated in the abstract)primaryHillmen 200783%55%P<0.0001
CR rateRandomised patients (297; analysis population not stated in the abstract)primaryHillmen 200724%2%P<0.0001Minimal residual disease was eliminated in 11 of 36 complete responders to alemtuzumab and in none with chlorambucil.
Primary publication: Hillmen P, Skotnicki AB, Robak T, Jaksic B, Dmoszynska A, Wu J, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25(35):5616-23. PubMedDOI

Appears in

Sources

  1. Hillmen P, Skotnicki AB, Robak T, Jaksic B, Dmoszynska A, Wu J, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25(35):5616-23.

    PubMedDOI