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Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study

Phase 2N = 93

Population
Relapsed or refractory B-cell CLL previously treated with alkylating agents and having failed fludarabine.
Design
Single-arm, multicentre study in 21 centres worldwide in relapsed or refractory B-cell CLL after alkylating agents and fludarabine failure. Alemtuzumab dose escalated to a target of 30 mg three times weekly for up to 12 weeks; infection prophylaxis mandatory. Responses assessed at weeks 4, 8 and 12; follow-up 34 months. Stated aim: an overall response rate of at least 20%. No NCT number in the PubMed record.
Arms
  • Alemtuzumab (experimental, n = 93): Alemtuzumab, target 30 mg three times weekly for up to 12 weeks
People
Keating MJ
Show the numbers
Results reported for Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study
EndpointAnalysisAlemtuzumabControlEffect
ORRITT (n = 93, as stated in the abstract)primaryKeating 200233%—Complete response 2%, partial response 31%. Single-arm study.
TTPAll 93 patientsprimaryKeating 2002median 4.7 months—Median time to progression 9.5 months in responders.
OSAll 93 patientsprimaryKeating 2002median 16 months (11.8–21.9)—Median survival 32 months in responders; 27 patients (29%) alive at data cut-off.
Results reported for Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study
EndpointAnalysisAlemtuzumabControlEffect
ORRITT (n = 93, as stated in the abstract)primaryKeating 200233%—Complete response 2%, partial response 31%. Single-arm study.
TTPAll 93 patientsprimaryKeating 2002median 4.7 months—Median time to progression 9.5 months in responders.
OSAll 93 patientsprimaryKeating 2002median 16 months (11.8–21.9)—Median survival 32 months in responders; 27 patients (29%) alive at data cut-off.
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%0246810Months (modelled)
  • Alemtuzumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAlemtuzumab
0100.0%
364.2%
641.3%
926.5%
1217.0%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Alemtuzumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAlemtuzumab
0100.0%
1064.8%
2042.0%
3027.3%
4017.7%
Primary publication: Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002;99(10):3554-61. PubMedDOI

Appears in

Sources

  1. Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002;99(10):3554-61.

    PubMedDOI