Campath-1H treatment of T-cell prolymphocytic leukemia in patients for whom at least one prior chemotherapy regimen has failed.

Abstract

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.

• Authors: M J Keating, B Cazin, S Coutré, R Birhiray, T Kovacsovics, W Langer, B Leber, T Maughan, K Rai, G Tjønnfjord, M Bekradda, M Itzhaki, P Hérait
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 20 Issue 1 Pg. 205-13 (Jan 01 2002) ISSN: 0732-183X [Print] United States
• PMID: 11773171 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antibodies, Neoplasm
• Antineoplastic Agents
• Alemtuzumab

Topics

• Adult
• Aged
• Aged, 80 and over
• Alemtuzumab
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antibodies, Neoplasm (adverse effects, therapeutic use)
• Antineoplastic Agents (adverse effects, therapeutic use)
• Consumer Product Safety
• Female
• Hematologic Diseases (chemically induced, epidemiology)
• Humans
• Infusions, Intravenous
• Leukemia, T-Cell (drug therapy, mortality)
• Male
• Middle Aged
• Opportunistic Infections (chemically induced, epidemiology)
• Retrospective Studies
• Salvage Therapy (methods)
• Survival Rate
• Time Factors