دورية أكاديمية
Activity of alemtuzumab monotherapy in treatment-naive, relapsed, and refractory severe acquired aplastic anemia.
| العنوان: | Activity of alemtuzumab monotherapy in treatment-naive, relapsed, and refractory severe acquired aplastic anemia. |
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| المؤلفون: | Scheinberg P; Hematology Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD 20892-1202, USA. scheinbp@mail.nih.gov, Nunez O, Weinstein B, Scheinberg P, Wu CO, Young NS |
| المصدر: | Blood [Blood] 2012 Jan 12; Vol. 119 (2), pp. 345-54. Date of Electronic Publication: 2011 Nov 08. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Intramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 7603509 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1528-0020 (Electronic) Linking ISSN: 00064971 NLM ISO Abbreviation: Blood Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2021- : [New York] : Elsevier Original Publication: New York, Grune & Stratton [etc.] |
| مواضيع طبية MeSH: | Salvage Therapy*, Anemia, Aplastic/*drug therapy , Antibodies, Monoclonal, Humanized/*therapeutic use , Antibodies, Neoplasm/*therapeutic use , Antilymphocyte Serum/*adverse effects , Cyclosporine/*adverse effects , Drug Resistance, Neoplasm/*drug effects , Neoplasm Recurrence, Local/*drug therapy, Adolescent ; Adult ; Aged ; Alemtuzumab ; Anemia, Aplastic/mortality ; Animals ; Antineoplastic Agents/therapeutic use ; Child ; Child, Preschool ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents/adverse effects ; Male ; Middle Aged ; Neoplasm Recurrence, Local/chemically induced ; Neoplasm Recurrence, Local/diagnosis ; Neoplasm Staging ; Prospective Studies ; Rabbits ; Survival Rate ; Treatment Outcome ; Young Adult |
| مستخلص: | Antithymocyte globulin (ATG) + cyclosporine is effective in restoring hematopoiesis in severe aplastic anemia (SAA). We hypothesized that the humanized anti-CD52 mAb alemtuzumab might be active in SAA because of its lymphocytotoxic properties. We investigated alemtuzumab monotherapy from 2003-2010 in treatment-naive, relapsed, and refractory SAA in 3 separate research protocols at the National Institutes of Health. Primary outcome was hematologic response at 6 months. For refractory disease, patients were randomized between rabbit ATG + cyclosporine (n = 27) and alemtuzumab (n = 27); the response rate for alemtuzumab was 37% (95% confidence interval [CI], 18%-57%) and for rabbit ATG 33% (95% CI, 14%-52%; P = .78). The 3-year survival was 83% (95% CI, 68%-99%) for alemtuzumab and 60% (95% CI, 43%-85%) for rabbit ATG (P = .16). For relapsed disease (n = 25), alemtuzumab was administered in a single-arm study; the response rate was 56% (95% CI, 35%-77%) and the 3-year survival was 86% (95% CI, 72%-100%). In treatment-naive patients (n = 16), alemtuzumab was compared with horse and rabbit ATG in a 3-arm randomized study; the response rate was 19% (95% CI 0%-40%), and the alemtuzumab arm was discontinued early. We conclude that alemtuzumab is effective in SAA, but best results are obtained in the relapsed and refractory settings. The present trials were registered at www.clinicaltrials.gov as NCT00195624, NCT00260689, and NCT00065260. |
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| معلومات مُعتمدة: | United States Intramural NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00065260; NCT00195624; NCT00260689 |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal, Humanized) 0 (Antibodies, Neoplasm) 0 (Antilymphocyte Serum) 0 (Antineoplastic Agents) 0 (Immunosuppressive Agents) 3A189DH42V (Alemtuzumab) 83HN0GTJ6D (Cyclosporine) |
| تواريخ الأحداث: | Date Created: 20111110 Date Completed: 20120306 Latest Revision: 20211021 |
| رمز التحديث: | 20221213 |
| مُعرف محوري في PubMed: | PMC3257005 |
| DOI: | 10.1182/blood-2011-05-352328 |
| PMID: | 22067384 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1528-0020 |
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| DOI: | 10.1182/blood-2011-05-352328 |