g the first few weeks of treatment, and appeared to approach steady state by approximately week 6, although there was marked inter-patient variability. The rise in serum Campath concentration corresponded with the reduction in malignant lymphocytosis.
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CLINICAL STUDIES
The safety and efficacy of Campath were eva luated in a multicenter, open-label, noncomparative study (Study 1) of 93 patients with B-cell chronic lymphocytic leukemia (B-CLL) who had been previously treated with alkylating agents and had failed treatment with fludarabine. Fludarabine failure was defined as lack of an objective partial (PR) or complete (CR) response to at least one fludarabine-containing regimen, progressive disease (PD) while on fludarabine treatment, or relapse within 6 months of the last dose of fludarabine. Patients were gradually escalated to a maintenance dose of Campath 30 mg intravenously three times per week for 4 to 12 weeks. Patients received premedication prior to infusion and anti-Pneumocystis carinii and anti-herpes prophylaxis while on treatment and for at least 2 months after the last dose of Campath.
Two supportive, multicenter, open-label, noncomparative studies of Campath enrolled a total of 56 patients with B-CLL (Studies 2 and 3). These patients had been previously treated with fludarabine or other chemotherapies. In Studies 2 and 3, the maintenance dose of Campath was 30 mg three times per week with treatment cycles of 8 and 6 weeks respectively. A slightly different dose escalation scheme was used in these trials. Premedication to ameliorate infusional reactions and anti-Pneumocystis carinii and anti-herpes prophylaxis were optional.
Objective tumor response rates and duration of response were determined using the NCI Working Group Response Criteria (1996). A comparison of patient characteristics and the results for each of these studies is summarized in Table 1. Time to event parameters, except for duration of response, are calculated from initiation of Campath therapy. Duration of response is calculated from the onset of the response.
Table 1: Summary of Patient Population and Outcomes
Study 1 (N=93) Study 2 (N=32) Study 3 (N=24)
Median Age in Years (Range) 66 (32 - 68) 57 (46 - 75) 62 (44-77)
Median Number of Prior Regimens (Range) 3 (2 - 7) 3 (1 - 10) 3 (1 - 8)
Prior Therapies: Alkylating Agents Fludarabine 100% 100% 100% 34% 92% 100%
Disease Characteristics: Rai Stage III/IV Disease B-Symptoms 76% 42% 72% 31% 71% 21%
Overall Response Rate (95% Confidence Interval) Complete Response Partial Response 33% (23%, 43%) 2% 31% 21% (8%, 33%) 0% 21% 29% (11%, 47%) 0% 29%
Median Duration of Response (months) (95% Confidence Interval) 7 (5, 8) 7 (5, 23) 11 (6, 19)
Median Time to Response (months) (95% Confidence Interval) 2 (1, 2) 4 (1, 5) 4 (2, 4)
Progression-Free Survival (months) (95% Confidence Interval) 4 (3, 5) 5 (3, 7) 7 (3, 9)
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INDICATIONS AND USAGE
Campath is indicated for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Dete |
