A phase II study of interleukin-2 in 49 patients with relapsed or refractory acute leukemia.

摘要: In this report we present the results of a multicenter phase II study high-dose recombinant Interleukin-2 (rIL-2) in patients with refractory or relapsed acute leukemia. Forty-nine myeloid leukemia (AML: 30 patients) lymphoblastic (ALL: 19 were included. Median age was years (range: 4-71). Four treated for primary disease and 45 (16 > 2nd relapse). Twenty-four (49%) had previously received bone marrow transplantation (allogeneic: 5, autologous: 19). Patients scheduled to receive three 5-day cycles rIL-2 given every other week. administered as bolus I.V. infusion 8 x 10(6) UI/m2 hours during cycle I 12 2 3. mean 76% planned dose. Main toxicity hematologic (grade IV thrombopenia: 84%). Hemodynamic metabolic toxicities lead treatment discontinuation 10 (20%). Strong immune activation achieved including significant increase activated T-cells Lymphokine-Activating-Killer cell (LAK) activity. Twenty-seven out AML could be evaluated response: 2(7%) complete remission (CR) which lasted 3 4 months. No response observed 18 assessable ALL patients, most whom (77 %) presented absolute drug resistance. These show that high dose regimen induces biological effects provides some anti-leukemic activity advanced Considering severe limited rate here, does not appear valuable therapeutic option such patients. However, undoubted cytokine invites further investigation especially minimal residual situation.