PHASE-IV GROUP-STUDY OF NATURAL HUMAN INTERFERON-ALPHA (HLBI) ON CHRONIC MYELOGENEOUS LEUKEMIA

Under the control of Kanagawa CML/HLBI phase IV study group in Japan, 18 cases out of registered 30 cases of chronic myelogeneous leukaemia consisting of 17 chronic phase and 1 accelerated phase, during July, 1 991 to January, 1992, were analyzed for their hematological responses and cytogentic responses preliminarily. Hematological response rate (P R + CR) was 83.3% including 50.0% of CR, as judged by Kimura's criteri a after treatment with HLBI alone (16 cases) or/and with other chemoth erapy (2 cases). The dosage and duration of HLBI therapy required to g et into the complete remission ranged from 212 to 1272 millions IU and between 6 to 42 weeks (mean value was 20 weeks), respectively. The cl onally proliferated leukocytes and decreased physiological hematopoies is started to recover from 2 to 4 weeks and reached their normal range s from 16 weeks after 6 millions IU of HLBI were administered every da y. In the 4 cases examined, 3 cases showed minimal cytogenetic respons es and a case showed no cytogenetic response. Slight and temporary adv erse effects were observed in 15 out of 18 cases (83.3%) including fev er, general malaise, appetite loss, eruption, diarrhea, glossitis, hyp ogustation, weight loss and local muscle pain.