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Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma.

Abstract
Dacetuzumab, a CD40-targeted, humanized antibody, mediates antitumor activity through effector cell functions and direct apoptotic signal transduction. Preclinical studies demonstrated synergistic activity between dacetuzumab, gemcitabine and rituximab against non-Hodgkin lymphoma in vivo. A phase 1b safety/efficacy study of dacetuzumab in combination with rituximab and gemcitabine was conducted in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Patients received dacetuzumab at doses of 8 or 12 mg/kg IV weekly with rituximab (375 mg/m(2) IV weekly in cycle 1, then every 28 days) and gemcitabine (1000 mg/m(2) IV, days 1, 8 and 15, or days 1 and 15). Thirty-three patients with a median age of 67 years were enrolled. Common adverse events (≥ 15%) were grade 1/2 cytokine release syndrome, nausea, fatigue, thrombocytopenia, headache, decreased appetite, dyspnea, neutropenia, pyrexia, anemia, diarrhea, edema, constipation and cough. Dacetuzumab-related grade 3/4 adverse events occurred infrequently. Six of 30 evaluable patients achieved a complete response (CR) and eight a partial response (PR) per investigator assessment for an overall response rate (ORR) of 47%.
AuthorsAndres Forero-Torres, Nancy Bartlett, Anne Beaven, Han Myint, Sunita Nasta, Donald W Northfelt, Nancy C Whiting, Jonathan G Drachman, Albert F Lobuglio, Craig H Moskowitz
JournalLeukemia & lymphoma (Leuk Lymphoma) Vol. 54 Issue 2 Pg. 277-83 (Feb 2013) ISSN: 1029-2403 [Electronic] United States
PMID22775314 (Publication Type: Journal Article)
Chemical References
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Monoclonal, Murine-Derived
  • Deoxycytidine
  • Rituximab
  • dacetuzumab
  • Gemcitabine
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
  • Antibodies, Monoclonal, Murine-Derived (administration & dosage)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Deoxycytidine (administration & dosage, analogs & derivatives)
  • Female
  • Humans
  • Lymphoma, Large B-Cell, Diffuse (drug therapy, mortality)
  • Male
  • Middle Aged
  • Pilot Projects
  • Recurrence
  • Rituximab
  • Treatment Outcome
  • Gemcitabine

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