PMID- 20491780
OWN - NLM
STAT- MEDLINE
DCOM- 20100818
LR  - 20191210
IS  - 1349-7006 (Electronic)
IS  - 1347-9032 (Linking)
VI  - 101
IP  - 8
DP  - 2010 Aug
TI  - Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with 
      follicular lymphoma pretreated with rituximab-based therapy.
PG  - 1840-5
LID - 10.1111/j.1349-7006.2010.01601.x [doi]
AB  - Inotuzumab ozogamicin (CMC-544), an antibody-targeted chemotherapeutic agent 
      composed of an anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic 
      antibiotic, specifically targets the CD22 antigen present in >90% of B-lymphoid 
      malignancies, rendering it useful for treating patients with B-cell non-Hodgkin 
      lymphoma (B-NHL). This phase I study evaluated the safety, tolerability, 
      efficacy, and pharmacokinetics of inotuzumab ozogamicin in Japanese patients. 
      Eligible patients had relapsed or refractory CD22-positive B-NHL without major 
      organ dysfunction. Inotuzumab ozogamicin was administered intravenously once 
      every 28 days (dose escalation: 1.3 and 1.8 mg/m(2)). All 13 patients had 
      follicular lymphoma, were previously treated with > or =1 rituximab-alone or 
      rituximab-containing chemotherapy, and were enrolled into two dose cohorts (1.3 
      mg/m(2), three patients; 1.8 mg/m(2), 10 patients). No patient had dose-limiting 
      toxicities, and the maximum tolerated dose, previously determined in non-Japanese 
      patients (1.8 mg/m(2)), was confirmed. Drug-related adverse events (AEs) included 
      thrombocytopenia (100%), leukopenia (92%), lymphopenia (85%), neutropenia (85%), 
      elevated AST (85%), anorexia (85%), and nausea (77%). Grade 3/4 drug-related AEs 
      in > or =15% patients were thrombocytopenia (54%), lymphopenia (31%), neutropenia 
      (31%), and leukopenia (15%). The AUC and C(max) of inotuzumab ozogamicin 
      increased dose-dependently with pharmacokinetic profiles similar to non-Japanese. 
      Seven patients had complete response (CR, 54%) including unconfirmed CR, four 
      patients had partial response (31%), and two patients had stable disease (15%). 
      The overall response rate was 85% (11/13). Inotuzumab ozogamicin was well 
      tolerated at doses up to 1.8 mg/m(2) and showed preliminary evidence of activity 
      in relapsed or refractory follicular lymphoma pretreated with 
      rituximab-containing therapy, warranting further investigations. This trial was 
      registered in ClinicalTrials.gov (NCT00717925).
FAU - Ogura, Michinori
AU  - Ogura M
AD  - Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, 
      Japan. mi-ogura@naa.att.ne.jp
FAU - Tobinai, Kensei
AU  - Tobinai K
FAU - Hatake, Kiyohiko
AU  - Hatake K
FAU - Uchida, Toshiki
AU  - Uchida T
FAU - Kasai, Masanobu
AU  - Kasai M
FAU - Oyama, Takashi
AU  - Oyama T
FAU - Suzuki, Tatsuya
AU  - Suzuki T
FAU - Kobayashi, Yukio
AU  - Kobayashi Y
FAU - Watanabe, Takashi
AU  - Watanabe T
FAU - Azuma, Teruhisa
AU  - Azuma T
FAU - Mori, Masakazu
AU  - Mori M
FAU - Terui, Yasuhito
AU  - Terui Y
FAU - Yokoyama, Masahiro
AU  - Yokoyama M
FAU - Mishima, Yuko
AU  - Mishima Y
FAU - Takahashi, Shunji
AU  - Takahashi S
FAU - Ono, Chiho
AU  - Ono C
FAU - Ohata, Junko
AU  - Ohata J
LA  - eng
SI  - ClinicalTrials.gov/NCT00717925
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100423
PL  - England
TA  - Cancer Sci
JT  - Cancer science
JID - 101168776
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - P93RUU11P7 (Inotuzumab Ozogamicin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects/pharmacokinetics
MH  - Antibodies, Monoclonal, Humanized
MH  - Antibodies, Monoclonal, Murine-Derived
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Female
MH  - Humans
MH  - Inotuzumab Ozogamicin
MH  - Lymphoma, Follicular/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Rituximab
EDAT- 2010/05/25 06:00
MHDA- 2010/08/19 06:00
CRDT- 2010/05/25 06:00
PHST- 2010/05/25 06:00 [entrez]
PHST- 2010/05/25 06:00 [pubmed]
PHST- 2010/08/19 06:00 [medline]
AID - CAS1601 [pii]
AID - 10.1111/j.1349-7006.2010.01601.x [doi]
PST - ppublish
SO  - Cancer Sci. 2010 Aug;101(8):1840-5. doi: 10.1111/j.1349-7006.2010.01601.x. Epub 
      2010 Apr 23.