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Campath-1H Treatment of T-Cell Prolymphocytic Leukemia in Patients for Whom at Least One Prior Chemotherapy Regimen Has Failed

From the M.D. Anderson Cancer Center, Houston, TX; Hôpital Claude Huriez, Lille; Cvitkovic & Associés Consultants, Kremlin-Bicêtre, France; Stanford University Medical Center, Stanford, CA; Marshfield Clinic, Marshfield, WI; Lausanne University Hospital, Lausanne, Switzerland; Evangelic Hospital, Essen-Werden, Germany; McMaster University/Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada; Velindre Hospital, Cardiff, United Kingdom; Long Island Jewish Medical Center, New York, NY; and National Hospital, Oslo, Norway.

Address reprint requests to Patrice Hérait, MD, Cvitkovic & Associés Consultants, 18-20 rue Pasteur, 94278 Kremlin-Bicêtre, France; email: p.herait{at}cvitkovic-ac.fr

PURPOSE: We conducted a retrospective analysis to evaluate the safety and efficacy of Campath-1H, an anti-CD52 humanized monoclonal antibody, in previously treated T-prolymphocytic leukemia (T-PLL) patients in a compassionate-use program.

PATIENTS AND METHODS: Seventy-six patients with T-PLL (including four chemotherapy-naive patients) received 3, 10, and 30 mg of Campath-1H on sequential days, followed by 30 mg three times weekly, as 2-hour intravenous infusions, for 4 to 12 weeks.

RESULTS: Median patient age was 60 years (range, 35 to 84). Spleen liver, lymph node, and skin involvement were present in 64%, 40%, 54%, and 18% of patients, respectively. All tested patients had CD2, CD7, CD4, and/or CD8 positivity, whereas CD5 and CD3 were positive in 98% and 96% of tested patients, respectively. The objective response rate was 51% (95% confidence interval [CI], 40% to 63%), with a 39.5% complete response (CR) rate (95% CI, 28% to 51%). The median duration of CR was 8.7 months (range, 0.13+ to 44.4), and median time to progression was 4.5 months (range, 0.1 to 45.4) compared with 2.3 months (range, 0.2 to 28.1) after first-line chemotherapy. The median overall survival was 7.5 months (14.8 months for CR patients). The most common Campath-1H–related adverse events were acute reactions during or immediately after infusions. Fifteen infectious episodes occurred during treatment in 10 patients (13%), leading to treatment discontinuation in three. Eight patients experienced possibly related, late-onset infections. Severe thrombocytopenia and/or neutropenia occurred in six patients (8%), leading to treatment discontinuation in four. Two treatment-related deaths occurred.

CONCLUSION: Campath-1H is an active drug in T-PLL patients for whom first-line therapy has failed. It has a favorable risk/benefit ratio and should be prospectively investigated in chemotherapy-naive patients.

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