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2.
Biol Blood Marrow Transplant ; 21(10): 1754-60, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26001695

ABSTRACT

The combination of reduced-intensity conditioning, (188)rhenium anti-CD66 radioimmunotherapy, and in vivo T cell depletion was successfully applied in elderly patients with acute myeloid leukemia or myelodysplastic syndrome. Within a prospective phase II protocol, we investigated whether a dose reduction of alemtuzumab (from 75 mg to 50 mg MabCampath) would improve leukemia-free survival by reducing the incidence of relapse. Fifty-eight patients (median age, 67 years; range, 54 to 76) received radioimmunotherapy followed by fludarabine 150 mg/m(2) and busulfan 8 mg/kg combined with either 75 mg (n = 26) or 50 mg (n = 32) alemtuzumab. Although we observed a trend towards a shorter duration of neutropenia in the 50 mg group (median, 19 versus 21 days; P = .07), the time from transplantation to neutrophil and platelet engraftment as well as the overall incidence of engraftment did not differ. The incidence of severe acute graft-versus-host disease tended to be higher after the lower alemtuzumab dose (17% versus 4%; P = .15). No significant differences in the cumulative incidences of relapse (38% versus 35%; P = .81) or nonrelapse mortality (46% versus 27%; P = .31) were observed. Accordingly, disease-free and overall survival were not significantly different between groups. Although the feasibility of radioimmunotherapy plus reduced-intensity conditioning could be demonstrated in elderly patients, the dose reduction of alemtuzumab had no positive impact on overall outcome.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal/therapeutic use , Graft vs Leukemia Effect , Immunoconjugates/therapeutic use , Leukemia, Myeloid, Acute/therapy , Lymphocyte Depletion/methods , Myelodysplastic Syndromes/therapy , Radioimmunotherapy , Radioisotopes/therapeutic use , Rhenium/therapeutic use , T-Lymphocytes/immunology , Transplantation Conditioning/methods , Aged , Alemtuzumab , Allografts , Antibodies, Monoclonal/immunology , Antibodies, Monoclonal, Humanized/administration & dosage , Antigens, CD/immunology , Antigens, Neoplasm/immunology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Busulfan/administration & dosage , Cell Adhesion Molecules/immunology , Combined Modality Therapy , Disease-Free Survival , Dose-Response Relationship, Drug , Feasibility Studies , Female , Graft vs Host Disease/epidemiology , Graft vs Host Disease/etiology , Humans , Leukemia, Myeloid, Acute/drug therapy , Leukemia, Myeloid, Acute/radiotherapy , Lymphocyte Depletion/adverse effects , Male , Middle Aged , Myelodysplastic Syndromes/drug therapy , Myelodysplastic Syndromes/radiotherapy , Neutropenia/etiology , Prospective Studies , Transplantation Conditioning/adverse effects , Vidarabine/administration & dosage , Vidarabine/analogs & derivatives
4.
Br J Haematol ; 148(6): 910-7, 2010 Mar.
Article in English | MEDLINE | ID: mdl-19995390

ABSTRACT

The addition of radioimmunotherapy to conventional and reduced-intensity conditioning has been shown to be feasible and effective. Within an ongoing prospective phase II trial, 22 patients with advanced myeloid malignancies and a median age of 65 years (range 54-76) received anti-CD66 Rhenium radioimmunotherapy followed by fludarabine (150 mg/m(2)), busulfan (8 mg/kg) and alemtuzumab (75 mg) before allogeneic haematopoietic stem cell transplantation from matched sibling (n = 7) and unrelated donors (n = 15). The extramedullary toxicity in the first 100 d post-transplantation was limited and all patients engrafted with complete donor chimaerism. The incidence of non-relapse mortality at day 100 and after 2 years was 4.5% and 23%, respectively. The probability of overall survival at 2 years was 40%. A comparison with a younger historical cohort (median age 57 years) having received the same dose of fludarabine and busulfan but neither radioimmunotherapy nor alemtuzumab showed no difference in outcome. Although the use of alemtuzumab reduced the incidence of acute graft-versus-host-disease, it was associated with a relapse incidence of 40% despite the incorporation of radioimmmunotherapy. In summary, we confirmed the feasibility of combined radioimmunotherapy and reduced-intensity conditioning in elderly patients. Further optimisation, probably involving less T cell depletion, is necessary before a randomized comparison with standard conditioning can be planned.


Subject(s)
Hematopoietic Stem Cell Transplantation/methods , Leukemia, Myeloid, Acute/radiotherapy , Radioimmunotherapy/methods , Rhenium/therapeutic use , Transplantation Conditioning/methods , Adult , Aged , Antigens, CD/immunology , Antigens, Neoplasm/immunology , Cell Adhesion Molecules/immunology , Epidemiologic Methods , Erythrocyte Transfusion , Female , Graft Survival , Graft vs Host Disease/etiology , Humans , Lymphocyte Depletion/methods , Male , Middle Aged , Platelet Transfusion , Radioimmunotherapy/adverse effects , Radioisotopes/therapeutic use , Recurrence
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