PMID- 23278639
OWN - NLM
STAT- MEDLINE
DCOM- 20140210
LR  - 20190116
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 54
IP  - 7
DP  - 2013 Jul
TI  - A multicenter phase II trial to determine the safety and efficacy of combination 
      therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine 
      and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study.
PG  - 1373-9
LID - 10.3109/10428194.2012.742521 [doi]
AB  - This phase II study to determine the safety and efficacy of denileukin diftitox 
      (DD) and cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) 
      enrolled patients with newly diagnosed peripheral T-cell lymphoma (PTCL). 
      Forty-nine received DD 18 mug/kg/day (days 1, 2) with CHOP (day 3) every 21 days 
      for </= 6-8 cycles. Intent-to-treat (ITT) and safety populations comprised all 
      patients. In the ITT population, the overall response rate was 65%, median 
      duration of response was 30 months and median progression-free survival was 12 
      months. Median overall survival was not attained at the end of the study, and the 
      overall survival rate was 63.3%. The two most frequent treatment-related adverse 
      events (AEs) were fatigue and nausea. Most frequent AEs >/= grade 3 within the 
      hematologic system were lymphopenia (24.5%), neutropenia (20.4%) and leukopenia 
      (18.4%). Three treatment-related deaths occurred. DD plus CHOP was well 
      tolerated, and progression-free and overall survival improved versus historical 
      comparison with CHOP alone. Confirmation in larger trials is warranted.
FAU - Foss, Francine M
AU  - Foss FM
AD  - Department of Medical Oncology, Yale Cancer Center, Yale Medical School, New 
      Haven, CT 06520, USA. francine.foss@yale.edu
FAU - Sjak-Shie, Nelida
AU  - Sjak-Shie N
FAU - Goy, Andre
AU  - Goy A
FAU - Jacobsen, Eric
AU  - Jacobsen E
FAU - Advani, Ranjana
AU  - Advani R
FAU - Smith, Mitchell R
AU  - Smith MR
FAU - Komrokji, Rami
AU  - Komrokji R
FAU - Pendergrass, Kelly
AU  - Pendergrass K
FAU - Bolejack, Vanessa
AU  - Bolejack V
LA  - eng
SI  - ClinicalTrials.gov/NCT00211185
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130129
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Diphtheria Toxin)
RN  - 0 (Interleukin-2)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 25E79B5CTM (denileukin diftitox)
RN  - 5J49Q6B70F (Vincristine)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - VB0R961HZT (Prednisone)
RN  - CHOP protocol
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Cyclophosphamide/administration & dosage
MH  - Diphtheria Toxin/administration & dosage
MH  - Doxorubicin/administration & dosage
MH  - Female
MH  - Humans
MH  - Interleukin-2/administration & dosage
MH  - Lymphoma, T-Cell, Peripheral/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Prednisone/administration & dosage
MH  - Recombinant Fusion Proteins/administration & dosage
MH  - Treatment Outcome
MH  - Vincristine/administration & dosage
MH  - Young Adult
EDAT- 2013/01/03 06:00
MHDA- 2014/02/11 06:00
CRDT- 2013/01/03 06:00
PHST- 2013/01/03 06:00 [entrez]
PHST- 2013/01/03 06:00 [pubmed]
PHST- 2014/02/11 06:00 [medline]
AID - 10.3109/10428194.2012.742521 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2013 Jul;54(7):1373-9. doi: 10.3109/10428194.2012.742521. Epub 
      2013 Jan 29.