Abstract
Abstract Background: Acute leukemia (AL) is a hematologic malignancy which posts a serious hazard to people's health, especially that of children's. At present, chemotherapy remains the most important therapeutic measure for AL. But there are 30% of patients who do not response to chemotherapy and 40%-60% of patients who become irresponsive eventually after relapse, which belong to refractory acute leukemia. Refractory acute leukemia (RAL), characterized by poor response to chemotherapy, low remission rate of induction chemotherapy and short-term survival, is a challenge for the treatment of AL. How to improve chemotherapy remission rate has always been essential to the treatment of refractory acute leukemia. To observe the effect of Compound Zhe Bei Granules (CZBG) combined with chemotherapy to improve clinical remission rate of patients with refractory acute leukemia, we designed this randomized multicenter, double-blind, placebo-controlled clinical trial under the guideline of Good Clinical Practice (GCP) regulation to study CZBG's effects on remission rate of chemotherapy in patients with refractory acute leukemia. Methods: In this multicenter double-blind, placebo-controlled clinical trial, we randomly assigned 238 patients who meet the diagnostic criteria of refractory acute leukemia to receive chemotherapy combined with CZBG or chemotherapy plus placebo using central (online) randomization system. When the clinical trial was finished, three cases were excluded which were not eligible for the inclusion criteria after verification. Clinical efficacy was calculated at the end of chemotherapeutic cycle, and, after the results were double revealed, we found there were 118 subjects in chemotherapy combined with CZBG (1 bag each time, twice daily) arm and 117 subjects in chemotherapy plus placebo (1 bag each time, twice daily) arm. Results: In the Full Analysis Set (FAS) where deaths due to disease progression were regarded as inefficacy, the percentages of CR, CR + PR were 32.35%, 50.00% respectively in chemotherapy combined with CZBG arm, and 23.08%, 35.58% in chemotherapy plus placebo arm. There was statistically significant difference between the two arms according to Z/Cmh test (P<0.05). In the Per Protocol Set (PPS), the CR, CR + PR rates were 33.67%, 52.04% respectively in chemotherapy plus CZBG arm and 24.24%, 37.37% in control arm. According to Z/Cmh test, there was statistical difference with or without CZBG (P<0.05). Conclusion: The above results prove that the CZBG in combination with chemotherapy can significantly improve chemotherapy remission rate after one cycle of treatment, showing good prospects for clinical application. Citation Format: Xinyi Chen, Li Hou, Shulian Yang, Wenhua Yang, Yuhong Zhou, Feng Liu, Hongyong Yang, Weizheng Sun, Dongyun Li, Yamei Xu. Clinical study on Compound Zhe Bei Granules (CZBG) combined with chemotherapy to improve the clinical efficacy of refractory acute leukemia. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 4661. doi:10.1158/1538-7445.AM2013-4661
Published Version
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