PMID- 28421390
OWN - NLM
STAT- MEDLINE
DCOM- 20171005
LR  - 20221207
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 106
IP  - 2
DP  - 2017 Aug
TI  - Ofatumumab combined with chlorambucil for previously untreated chronic 
      lymphocytic leukemia: a phase I/II, open-label study in Japan.
PG  - 240-247
LID - 10.1007/s12185-017-2233-1 [doi]
AB  - Elderly/comorbid patients with chronic lymphocytic leukemia (CLL) require 
      low-toxicity treatments. Internationally, the standard treatment for such 
      patients is chlorambucil and an anti-CD20 therapy; however, chlorambucil is not 
      approved in Japan. The aim of the present study was to evaluate the safety, 
      efficacy and pharmacokinetics of ofatumumab in combination with chlorambucil in 
      Japanese patients with previously untreated CLL who were inappropriate for 
      fludarabine-based therapy. Ten patients were enrolled and treated in this study, 
      all of whom received at least one dose of the study drugs. The tolerability of 
      the treatment was confirmed initially with three patients. The overall response 
      rate was 50%, as determined by the Independent Review Committee (IRC) with 
      computerized tomography. All patients were alive at follow-up, and only one 
      patient had progressive disease. The most common treatment-related adverse events 
      (AEs) were thrombocytopenia (n = 10), neutropenia (n = 9) and rash (n = 6). One 
      grade 3 serious AE related to the study drug occurred (hypoxia). The results 
      indicate that ofatumumab combined with chlorambucil is an effective treatment for 
      Japanese CLL patients, with a manageable safety profile.
FAU - Hatake, Kiyohiko
AU  - Hatake K
AD  - Department of Hematology and Oncology, Cancer Institute Hospital, Japanese 
      Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. 
      khatake@jfcr.or.jp.
FAU - Ogura, Michinori
AU  - Ogura M
AD  - Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, 
      Aichi, Japan.
AD  - Department of Hematology, Tokai Central Hospital, Kakamigahara, Gifu, Japan.
FAU - Takada, Kohichi
AU  - Takada K
AD  - Department of Medical Oncology and Hematology, Sapporo Medical University School 
      of Medicine, Sapporo, Japan.
FAU - Taniwaki, Masafumi
AU  - Taniwaki M
AD  - Division of Hematology and Oncology, Graduate School of Medical Science, Kyoto 
      Prefectural University of Medicine, Kyoto, Japan.
FAU - Zhang, Fanghong
AU  - Zhang F
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Fujita, Taizo
AU  - Fujita T
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Ando, Kiyoshi
AU  - Ando K
AD  - Department of Hematology and Oncology, Tokai University School of Medicine, 
      Isehara, Kanagawa, Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20170418
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 18D0SL7309 (Chlorambucil)
RN  - M95KG522R0 (ofatumumab)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects/pharmacokinetics
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Asian People
MH  - Chlorambucil/administration & dosage/adverse effects/pharmacokinetics
MH  - Exanthema/chemically induced
MH  - Female
MH  - Humans
MH  - Japan
MH  - Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Neutropenia/chemically induced
MH  - Thrombocytopenia/chemically induced
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chlorambucil
OT  - Chronic lymphocytic leukemia
OT  - Ofatumumab
OT  - Untreated
EDAT- 2017/04/20 06:00
MHDA- 2017/10/06 06:00
CRDT- 2017/04/20 06:00
PHST- 2016/12/27 00:00 [received]
PHST- 2017/04/04 00:00 [accepted]
PHST- 2017/03/30 00:00 [revised]
PHST- 2017/04/20 06:00 [pubmed]
PHST- 2017/10/06 06:00 [medline]
PHST- 2017/04/20 06:00 [entrez]
AID - 10.1007/s12185-017-2233-1 [pii]
AID - 10.1007/s12185-017-2233-1 [doi]
PST - ppublish
SO  - Int J Hematol. 2017 Aug;106(2):240-247. doi: 10.1007/s12185-017-2233-1. Epub 2017 
      Apr 18.