PMID- 20038235
OWN - NLM
STAT- MEDLINE
DCOM- 20100423
LR  - 20210102
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 51
IP  - 2
DP  - 2010 Feb
TI  - A phase I study of dacetuzumab (SGN-40, a humanized anti-CD40 monoclonal 
      antibody) in patients with chronic lymphocytic leukemia.
PG  - 228-35
LID - 10.3109/10428190903440946 [doi]
AB  - Despite advances in therapy, chronic lymphocytic leukemia remains an incurable 
      disease and novel, effective therapies are needed. In this open-label, 
      dose-escalation, phase I study, dacetuzumab (IgG1 humanized monoclonal antibody) 
      was administered to 12 adults, all of whom had received several prior systemic 
      therapies (median, 4; range, 2-11). Intrapatient dose escalation (maximum weekly 
      doses of 3-8 mg/kg) was used to diminish first-dose-related inflammatory 
      symptoms. No dose-limiting toxicities or dose-dependent trends in adverse events 
      (AEs) were observed. The most common AEs (in >/=2 patients) were fatigue, 
      headache, anorexia, conjunctivitis, hyperhidrosis, and night sweats, all of which 
      were mild or moderate. No deaths, serious AEs, or discontinuations due to AEs 
      occurred. Although no patient achieved an objective response, five patients 
      demonstrated stable disease after 1 cycle of therapy, with no discernable 
      correlation between dacetuzumab dose and outcome. This modest single-agent 
      activity may warrant further testing of dacetuzumab in combination with other 
      chronic lymphocytic leukemia therapies.
FAU - Furman, Richard R
AU  - Furman RR
AD  - Division of Hematology/Oncology, Weill Cornell Medical College, New York, NY 
      10065, USA. rrfurman@med.cornell.edu
FAU - Forero-Torres, Andres
AU  - Forero-Torres A
FAU - Shustov, Andrei
AU  - Shustov A
FAU - Drachman, Jonathan G
AU  - Drachman JG
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - UT59FF4T5X (dacetuzumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anorexia/chemically induced
MH  - Antibodies, Monoclonal/adverse effects/pharmacokinetics/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Conjunctivitis/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Fatigue/chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Leukemia, Lymphocytic, Chronic, B-Cell/blood/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2009/12/30 06:00
MHDA- 2010/04/24 06:00
CRDT- 2009/12/30 06:00
PHST- 2009/12/30 06:00 [entrez]
PHST- 2009/12/30 06:00 [pubmed]
PHST- 2010/04/24 06:00 [medline]
AID - 10.3109/10428190903440946 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2010 Feb;51(2):228-35. doi: 10.3109/10428190903440946.