Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Phase 2 Completed 61 enrolled GlaxoSmithKline

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.

Timeline

Start: 2009-05
Primary completion: 2011-07
Completion: 2011-09

Publications

Matasar MJ, Czuczman MS, Rodriguez MA, Fennessy M, Shea TC, Spitzer G, Lossos IS, Kharfan-Dabaja MA, Joyce R, Fayad L, Henkel K, Liao Q, Edvardsen K, Jewell RC, Fecteau D, Singh RP, Lisby S, Moskowitz CH. Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma. Blood. 2013 Jul 25;122(4):499-506. doi: 10.1182/blood-2012-12-472027. Epub 2013 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ofatumumab	Monoclonal antibody	1000 mg	—
Background	2-MERCAPTOETHANESULFONIC ACID	Small molecule	—	—
Background	Carboplatin	Small molecule	800 mg	—
Background	Cisplatin	Other / unclassified	100 mg/m2	—
Background	Cytarabine	Small molecule	2000 mg/m2	—
Background	Dexamethasone	Small molecule	40 mg	—
Background	Etoposide	Small molecule	100 mg/m2	—
Background	Ifosfamide	Small molecule	5000 mg/m2	—

Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Summary

Timeline

Publications

Drugs

Indications