Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study
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Discussion
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Implication
Multicenter clinical trial reveals significant response rates with alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia, indicating a valuable therapeutic option.
Key Points
- Investigate the efficacy, safety, and clinical benefit of alemtuzumab in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who failed fludarabine therapy.
- Multicenter study involving 93 patients across 21 centers worldwide with relapsed/refractory B-cell chronic lymphocytic leukemia previously treated with alkylating agents and fludarabine.
- Alemtuzumab was titrated to a target dose of 30 mg 3 times weekly for up to 12 weeks with mandatory antimicrobial prophylaxis starting on day 8.
- Response assessments occurred at weeks 4, 8, and 12, with a total follow-up period of 34 months.
- The overall objective response rate in the intent-to-treat population (n = 93) was 33% (2% complete response, 31% partial response), with a median time to response of 1.5 months.
- Median time to disease progression was 4.7 months overall and 9.5 months for responders; median overall survival was 16 months (95% CI: 11.8–21.9) overall and 32 months for responders.
- Infusion-related toxicities (mostly grade 1–2) occurred primarily in week 1, and grade 3 or 4 infections occurred in 26.9% of all patients (25/93) but in only 9.7% of responders (3/31).
Cite This Study
Keating et al. (2002) studied this question.