Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study) - Randomized trial with or without maintenance/intensification therapy in patients with acute promyelocytic leukemia (JALSG APL97 study)

Japan Adult Leukemia Study Group0 个研究点目标入组 234 人开始时间: 2005年9月14日最近更新: 2023年10月17日

适应症

试验速览

Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission (CR). 2) A total of 175 patients negative for PML-RARalpha at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86). 3) Predicted 6-year DFS was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the two groups (P = 0.20). 4) Predicted 6-year survival of patients assigned to the observation was 98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = 0.014).

•1. Uncontrolled active infection 2. Past history of myocardial infarction or cardiac failure 3. Past history of renal failure 4. Uncontrolled diabetes mellitus 5. Liver cirrhosis 6. Leukemic involvement in the CNS 7. Another severe and/or life threatening disease 8. Pregnant and/or lactating woman 9. Positive for HIV antibody test

发起方