Deferasirox for the treatment of iron overload after allogeneic hematopoietic cell transplantation: multicenter phase I study (KSGCT1302) View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-01-05

AUTHORS

Takayoshi Tachibana, Junya Kanda, Shinichiro Machida, Takeshi Saito, Masatsugu Tanaka, Yuho Najima, Satoshi Koyama, Takuya Miyazaki, Eri Yamamoto, Masahiro Takeuchi, Satoshi Morita, Yoshinobu Kanda, Heiwa Kanamori, Shinichiro Okamoto, Kanto Study Group for Cell Therapy (KSGCT)

ABSTRACT

The aim of this study was to assess the safety and optimal dose of deferasirox for the treatment of iron overload after allogeneic hematopoietic cell transplantation (HCT). The primary endpoint was the maximum tolerated dose of deferasirox that was determined by the intrapatient dose escalation methods. A total of 16 patients with post-HCT iron overload were enrolled in the study. After excluding one case of early relapse, 15 remained evaluable. Their median age was 42 years (range 22–68). Median time from HCT to deferasirox administration was 9 months (range 6–84). Deferasirox was started at a dose of 5 mg/kg, and the dose was increased to 7.5 and 10 mg/kg every 4 weeks unless there were no grade ≥ 2 of adverse events. Achievement rates of planned medication were 80% in 5 mg/kg (12 of 15), 73% in 7.5 mg/kg (11 of 15), and 60% in 10 mg/kg (9 of 15), respectively. The reasons for discontinuation of the drug were grade 2 of adverse events (n = 4), late relapse (n = 1), and self-cessation (n = 1). None of the patients developed grade ≥ 3 of adverse events or exacerbation of GVHD. Among 11 evaluable cases, mean value of ferritin decreased from 1560 ng/ml pre-treatment to 1285 ng/ml post-treatment. These data suggested that 10 mg/kg of deferasirox may be maximum tolerated dose when given after HCT. Our dose escalating method of deferasirox is useful to identify the optimal dosage of the drug in each patient.Trial RegistrationUMIN000011251 More... »

PAGES

578-585

Journal

TITLE

International Journal of Hematology

ISSUE

5

VOLUME

107

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-017-2396-9

DOI

http://dx.doi.org/10.1007/s12185-017-2396-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1100201980

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29305770


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27 schema:description The aim of this study was to assess the safety and optimal dose of deferasirox for the treatment of iron overload after allogeneic hematopoietic cell transplantation (HCT). The primary endpoint was the maximum tolerated dose of deferasirox that was determined by the intrapatient dose escalation methods. A total of 16 patients with post-HCT iron overload were enrolled in the study. After excluding one case of early relapse, 15 remained evaluable. Their median age was 42 years (range 22–68). Median time from HCT to deferasirox administration was 9 months (range 6–84). Deferasirox was started at a dose of 5 mg/kg, and the dose was increased to 7.5 and 10 mg/kg every 4 weeks unless there were no grade ≥ 2 of adverse events. Achievement rates of planned medication were 80% in 5 mg/kg (12 of 15), 73% in 7.5 mg/kg (11 of 15), and 60% in 10 mg/kg (9 of 15), respectively. The reasons for discontinuation of the drug were grade 2 of adverse events (n = 4), late relapse (n = 1), and self-cessation (n = 1). None of the patients developed grade ≥ 3 of adverse events or exacerbation of GVHD. Among 11 evaluable cases, mean value of ferritin decreased from 1560 ng/ml pre-treatment to 1285 ng/ml post-treatment. These data suggested that 10 mg/kg of deferasirox may be maximum tolerated dose when given after HCT. Our dose escalating method of deferasirox is useful to identify the optimal dosage of the drug in each patient.Trial RegistrationUMIN000011251
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34 schema:keywords GVHD
35 achievement rate
36 administration
37 adverse events
38 age
39 aim
40 allogeneic hematopoietic cell transplantation
41 cases
42 cell transplantation
43 data
44 deferasirox
45 deferasirox administration
46 discontinuation
47 dosage
48 dose
49 dose of deferasirox
50 drugs
51 early relapse
52 endpoint
53 escalation method
54 evaluable cases
55 events
56 exacerbation
57 exacerbation of GVHD
58 ferritin
59 grade
60 grade 2
61 hematopoietic cell transplantation
62 intrapatient
63 iron overload
64 late relapse
65 maximum
66 mean value
67 median age
68 median time
69 medications
70 method
71 months
72 multicenter phase I
73 optimal dosage
74 optimal dose
75 overload
76 patients
77 phase I
78 primary endpoint
79 rate
80 reasons
81 relapse
82 safety
83 study
84 time
85 total
86 transplantation
87 treatment
88 values
89 weeks
90 years
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