PMID- 23846385
OWN - NLM
STAT- MEDLINE
DCOM- 20140618
LR  - 20221207
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 98
IP  - 2
DP  - 2013 Aug
TI  - A phase I/II study of ofatumumab (GSK1841157) in Japanese and Korean patients 
      with relapsed or refractory B-cell chronic lymphocytic leukemia.
PG  - 164-70
LID - 10.1007/s12185-013-1393-x [doi]
AB  - The tolerability, efficacy, safety and pharmacokinetic profile of a human 
      anti-CD20 monoclonal antibody, ofatumumab, was evaluated in this phase I/II study 
      in patients with relapsed or refractory B-cell chronic lymphocytic leukemia 
      (B-CLL). This study consisted of two parts. Tolerability was assessed in phase I 
      (Part A), while the overall response rate (ORR) was assessed in phase II 
      (comprising Parts A and B). Three patients were enrolled in Part A, and another 
      seven patients were enrolled in Part B. Ofatumumab 300 mg was given at the first 
      infusion, followed by seven weekly and four monthly infusions of 2000 mg. No 
      patients experienced dose-limiting toxicity, and tolerability was confirmed. The 
      ORR was 70 %. The most commonly reported adverse events (AEs) were leukopenia, 
      neutropenia, and lymphopenia. No patients discontinued the study due to AEs. 
      Plasma concentrations of ofatumumab prior to the next weekly dose increased 
      steadily over the 8 weeks and did not reach steady state; with monthly dosing, 
      pre-dose ofatumumab concentrations decreased. Inter-patient variability of 
      pharmacokinetic parameters was larger after the first dose than after the later 
      dose. In conclusion, this phase I/II study suggests that ofatumumab provides 
      favorable safety and efficacy in Japanese/Korean patients with relapsed or 
      refractory B-CLL.
FAU - Ogawa, Yoshiaki
AU  - Ogawa Y
AD  - Department of Hematology and Oncology, Tokai University School of Medicine, 
      Shimokasuya 143, Isehara, Kanagawa 259-1193, Japan. yoshioga@is.icc.u-tokai.ac.jp
FAU - Ogura, Michinori
AU  - Ogura M
FAU - Suzuki, Tatsuya
AU  - Suzuki T
FAU - Ando, Kiyoshi
AU  - Ando K
FAU - Uchida, Toshiki
AU  - Uchida T
FAU - Shirasugi, Yukari
AU  - Shirasugi Y
FAU - Tobinai, Kensei
AU  - Tobinai K
FAU - Lee, Je Hwan
AU  - Lee JH
FAU - Kase, Masazumi
AU  - Kase M
FAU - Katsura, Koichi
AU  - Katsura K
FAU - Hotta, Tomomitsu
AU  - Hotta T
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20130712
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - M95KG522R0 (ofatumumab)
SB  - IM
MH  - Aged
MH  - *Antibodies, Monoclonal/administration & dosage/adverse effects/pharmacokinetics
MH  - Antibodies, Monoclonal, Humanized
MH  - Asian People
MH  - Female
MH  - Humans
MH  - Japan
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/blood/drug therapy
MH  - Lymphopenia/blood/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Neutropenia/blood/chemically induced
MH  - Republic of Korea
EDAT- 2013/07/13 06:00
MHDA- 2014/06/19 06:00
CRDT- 2013/07/13 06:00
PHST- 2012/10/17 00:00 [received]
PHST- 2013/06/17 00:00 [accepted]
PHST- 2013/06/12 00:00 [revised]
PHST- 2013/07/13 06:00 [entrez]
PHST- 2013/07/13 06:00 [pubmed]
PHST- 2014/06/19 06:00 [medline]
AID - 10.1007/s12185-013-1393-x [doi]
PST - ppublish
SO  - Int J Hematol. 2013 Aug;98(2):164-70. doi: 10.1007/s12185-013-1393-x. Epub 2013 
      Jul 12.