Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia.

Österborg, Anders; Dyer, Martin J. S.; Bunjes, Donald; Pangalis, Gerassimos A.; Bastion, Y.; Catovsky, Daniel; Mellstedt, Håkan

doi:10.1200/jco.1997.15.4.1567

Cited by 464 publications

(297 citation statements)

References 24 publications

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“…In an earlier study by Osterborg et al, patients who developed Pneumocystis carinii pneumonia (PCP) or septicemia tended to be more heavily pretreated or resistant to fludarabine treatment [46]. In another study in patients with relapsed or fludarabine-refractory CLL, infections were reported in 42% of patients, predominantly in the non-responder group.…”

Section: Infectious Events Associated With Alemtuzumab Therapymentioning

confidence: 99%

Management of infections in patients with chronic lymphocytic leukemia treated with alemtuzumab

et al. 2008

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International audienceInfection is a significant cause of morbidity and death in patients with chronic lymphocytic leukemia (CLL). Increased infectious events may arise from the multiple courses of immunosuppressive therapy and progressive deterioration of a patient's immune system over the course of disease. The humanized, anti-CD52 monoclonal antibody alemtuzumab (Campath or Campath-1H) has shown notable activity for both untreated and fludarabine-refractory CLL. The antibody not only targets malignant cells but also affects normal, healthy immune cells. The cumulative effects of the malignancy and successive courses of treatments adversely impinge on a patient's defense response to certain bacterial, fungal, and viral infections. In this review article, we provide an overview of common infectious events associated with alemtuzumab therapy in CLL. We also discuss recommendations for effectively monitoring and managing infections in CLL patients

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Section: Infectious Events Associated With Alemtuzumab Therapymentioning

confidence: 99%

Management of infections in patients with chronic lymphocytic leukemia treated with alemtuzumab

et al. 2008

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“…13 Binding of alemtuzumab to CD52 on target cells may cause cell death by 3 different mechanisms: complement activation, 14 antibody-dependent cellular cytotoxicity, 15,16 and apoptosis. 17 Based on prior reports from small studies demonstrating that alemtuzumab was an effective salvage therapy for patients in whom fludarabine had failed, 18 this study was implemented to confirm these encouraging results in a larger cohort of patients with advanced B-CLL. These patients had all been treated previously with alkylating agents and had documented failure to fludarabine therapy.…”

Section: Introductionmentioning

confidence: 99%

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

Keating

Flinn

Jain

et al. 2002

Blood

868

561

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This study investigated the efficacy, safety, and clinical benefit of alemtuzumab (Campath-1H) for patients with relapsed or refractory B-cell chronic lymphocytic leukemia exposed to alkylating agents and having failed fludarabine therapy. Ninety-three patients received alemtuzumab in 21 centers worldwide, with the aim to obtain an overall response rate of at least 20%. Dosage was increased gradually (target 30 mg, 3 times weekly, for a maximum of 12 weeks). Infection prophylaxis was mandatory, beginning on day 8, and continuing for a minimum of 2 months after treatment. Responses were assessed at weeks 4, 8, and 12, and patients were followed for 34 months. Overall objective response in the intent-to-treat population (n ‫؍‬ 93) was 33% (CR 2%, PR 31%). Median time to response was 1.5 months (range, 0.4-3.7 months). Median time to progression was 4.7 months overall, 9.5 months for responders. At data cut-off, 27 patients (29%) were alive; overall median survival was 16 months (95% CI: 11.8-21.9) and 32 months for responders. Nineteen responders survived more than 21 months. Clinical benefit was observed both in responders and in patients with stable disease. The most common adverse events were related to infusion, generally grade 1 or 2 in severity, occurring mainly in the first week. Grade 3 or 4 infections were reported in 25 patients (26.9%). However, only 3 (9.7%) of 31 patients who responded to alemtuzumab treatment developed grade 3 or 4 infections on the study. Alemtuzumab induced significant responses in these patients with clinical benefit in the majority and with acceptable toxicity in a high-risk group. (Blood. 2002; 99:3554-3561)

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“…4 It been found to be effective in CLL when used alone as both front-line and salvage therapy, 5 and also seems to be effective in patients whose leukaemic cells carry the 17p deletion. 6,7 However, although the first published studies of alemtuzumab in the treatment of CLL go back more than 10 years, 8 some areas of uncertainty still remain. These mainly concern the fear of adverse events related to the profound lymphopenia and associated infections induced by the drug when the classic and consolidated intravenous schedule of 30 mg three times a week for 12 weeks is used because, although highly effective, it may lead to infusionrelated side effects and potentially life-threatening infections.…”

Section: Introductionmentioning

confidence: 99%

Low-dose subcutaneous alemtuzumab in refractory chronic lymphocytic leukaemia (CLL): results of a prospective, single-arm multicentre study

et al. 2009

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Alemtuzumab is active in chronic lymphocytic leukaemia (CLL) patients refractory to alkylators and fludarabine. The aim of this study was to determine the efficacy and safety of subcutaneous alemtuzumab at low dose (10 mg three times per week, for 18 weeks) to 49 patients with pre-treated CLL. The overall response rate was 53%, including 27% of complete responses; it was 42% in patients over 70 years, and 54% in the fludarabine-resistant patients. Forty-five percent of the patients with an unfavourable karyotype responded, including 60% of those with the 17p-aberration. After a median follow-up of 25 months, the median overall time to disease progression was 8 months (responders 12 months, non-responders 4 months). The median overall time to alternative treatment was 9 months (responders 17 months, non-responders 6 months) and median overall survival was 30 months. The treatment was well tolerated: grade IV neutropenia was observed in 17%, and cytomegalovirus (CMV) reactivation in 24% of the patients, with no CMV disease. We observed a total of 30 infections (50% during treatment and 50% during the 12-month follow-up), only one-third of which was severe. This study confirms that lowdose subcutaneous alemtuzumab is effective in poor prognosis CLL, and has a particularly favourable toxicity profile.

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Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia.

Cited by 464 publications

References 24 publications

Management of infections in patients with chronic lymphocytic leukemia treated with alemtuzumab

Management of infections in patients with chronic lymphocytic leukemia treated with alemtuzumab

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

Low-dose subcutaneous alemtuzumab in refractory chronic lymphocytic leukaemia (CLL): results of a prospective, single-arm multicentre study

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