Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2010-1-22
pubmed:databankReference
pubmed:abstractText
Preclinical data demonstrate enhanced antitumor effect when lumiliximab, an anti-CD23 monoclonal antibody, is combined with fludarabine or rituximab. Clinical data from a phase 1 trial with lumiliximab demonstrated an acceptable toxicity profile in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). We therefore pursued a phase 1/2 dose-escalation study of lumiliximab added to fludarabine, cyclophosphamide, and rituximab (FCR) in previously treated CLL patients. Thirty-one patients received either 375 mg/m(2) (n = 3) or 500 mg/m(2) (n = 28) of lumiliximab in combination with FCR for 6 cycles. The toxicity profile was similar to that previously reported for FCR in treatment of relapsed CLL. The overall response rate was 65%, with 52% of patients achieving a complete response (CR), which compares favorably with the CR rate previously reported for the FCR regimen alone in relapsed CLL. The estimated median progression-free survival for all responders was 28.7 months. The addition of lumiliximab to FCR therapy is feasible, achieves a high CR rate, and does not appear to enhance toxicity in previously treated patients with CLL. A randomized trial comparing lumiliximab plus FCR with FCR alone is underway to define the benefit of this combination in relapsed CLL. This trial was registered at clinicaltrials.gov as NCT00103558.
pubmed:grant
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-10477712, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-11136261, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-11733578, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-11764079, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-11840283, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-12517774, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-12592330, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-15329427, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-15767647, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-15767648, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-16219797, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-16344317, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-16353201, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-16755224, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-17283363, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-17283364, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-17658394, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-17671129, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-18032710, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-7888675, http://linkedlifedata.com/resource/pubmed/commentcorrection/19843887-8652811
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
1528-0020
pubmed:author
pubmed:issnType
Electronic
pubmed:day
21
pubmed:volume
115
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
489-95
pubmed:dateRevised
2011-7-20
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
pubmed:affiliation
The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA. john.byrd@osumc.edu
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II, Clinical Trial, Phase I, Research Support, N.I.H., Extramural