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Treatment of CD33+ acute myeloid leukemia and myelodysplastic syndrome with gemtazumab ozogamicin, IL-11 and low weight heparin Preliminary results

Treatment of CD33+ acute myeloid leukemia and myelodysplastic syndrome with gemtazumab ozogamicin, IL-11 and low weight heparin Preliminary results

Blood 102(11): 256b, November 16

Gemtazumab ozogamicin (Mylotarg) is an antibody-targeted chemotherapeutic agent consisting of a humanized anti-CD33 antibody linked to calicheamicin, a potent antitumor antibiotic. In this study eleven (11) patients (age range: 24-78 years) with diagnosis of CD33+ acute myeloid leukemia were treated with Mylotarg: one patient with de novo AML reluctant to chemotherapy, one old man with de novo AML, two patients refractory to chemotherapy, two patients in relapse, three patients with AML secondary to a myelodysplastic syndrome (MDS), one patient with secondary AML, one patient in relapse after transplant of autologous progenitor cells. The Gemtazumab Ozogamicin (9 mg/m2) was administered intravenously in two doses given two weeks apart as induction treatment and then every 6 weeks as maintenance. Low weight heparin and IL-11 were used in some of these patients. Transient fever and chills were seen only in one patient, while transient elevations of AST/ALT, bilirubin and moderately myelosuppression were seen in all patients. The patient with de novo AML was a 65 years-old woman who suffered of congenital impaired hearing. This patient entered in complete remission after two doses of Mylotarg; she received maintenance doses during 8 months. She had a good quality of life for 8 months and then relapsed. Chemotherapy was administered but she did not respond to it and she died in relapse. Another patient, a 50 years-old woman refractory to chemotherapy also entered in complete remission with Mylotarg and survived 9 months with good quality of life; then she relapsed, did not respond to chemotherapy and died. One patient a 78 years-old man with de novo AML did not respond to Mylotarg. One 28 years-old patient refractory to chemotherapy entered in complete remission with Mylotarg; he has been in complete remission for two years. One patient, a 24 years-old woman in third relapse only got partial remission. Three patients with AML secondary to MDS, one with secondary leukemia, one patient with AML-M3 in second relapse and one patient in relapse post transplant of autologous progenitor cells did not respond to Mylotarg. The IL-11 helped to decreased the number of platelets transfusion in the myelosuppression phase post-Mylotarg and the low MW heparin prevented thrombotic episodes as VOD. In summary 11 patients with AML were treated with Mylotarg. A complete remission was obtained in three of them with a remission period ranging from 8 to 18. These patients had a good quality of life. Mylotarg alone does not increase the rate of survival in AML patients, but it could be useful in combination with chemotherapy in new protocols. IL-11 decreases the requirement of platelets post Mylotarg and low molecular heparin probably prevents VOD.

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Accession: 035980354

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