[Multi-institutional randomized controlled clinical trial on China made 4-demethoxydaunokrubicin (IDA) in the treatment of acute leukemia].
OBJECTIVE
To evaluate the efficacy and safety of IDA (Haizheng Parmacy, China) in the treatment of acute leukemia.


METHODS
A multi-institutional single-blind randomized controlled clinical trial was carried out. A total of 155 newly diagnosed patients with AML and ALL were enrolled. The patients were randomly divided into two groups, one was given IDA (n = 77) and the other given zevodas (Pharnacia & Upjohn, n = 78) for comparison.


RESULTS
All the patients enrolled in this trial were eligible for assessment of side effects, and 129 patients for evaluation of overall response rate. In patients treated with IDA vs zevodas, the overall response rate (OR) was 78.1% vs 76.9%, CR was 68.8% vs 67.7%; in AML patients, OR was 82.4% vs 71.8%, and CR was 76.5% vs 64.1%; in ALL patients, OR was 80.0% vs 81.8%, and CR was 68.0% vs 68.2%. There was no sitatistically significant difference in hematologic and non-hematologic toxicities between the two groups.


CONCLUSIONS
The efficacy of IDA in the treatment of acute leukemia is comparable to that of zevodas. Both have similar toxic side effects.
Liu
Yan
Y
Department of Hematology, Third Hospital, Beijing University, Beijing 100083, China.
Ke
Xiao-yan
XY
Ma
Jun
J
Shen
Zhi-xiang
ZX
Zhang
Xiao-hong
XH
Du
Xin
X
Zhao
Yi-ming
YM
Lü
Jing-qiao
JQ
Zhan
Zhao-min
ZM
Zeng
Xiao-ying
XY
Xu
Xiao-hua
XH
Lu
Ze-sheng
ZS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000009:adverse effects / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D016037:Single-Blind Method
D000903:Antibiotics, Antineoplastic; D015255:Idarubicin