Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

Completed · Phase 3

Conditions studied: Lymphoma, Large-Cell, Diffuse

In brief

This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.

Key facts

Study ID

NCT01014208

Run by

GlaxoSmithKline

People needed

447

Starts

2010-03-01

Expected to finish

2014-11-01

Last updated by the study team

2015-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with CD20 positive DLBCL or grade 3b follicular lymphoma (FL) at original diagnosis.
• Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline- or anthracenedione-based chemotherapy as defined by the protocol.
• CT with involvement of 2 or more clearly demarcated lesions/ nodes with a long axis > 1.5 cm and short axis >= 1.0cm or 1 clearly demarcated lesion/ node with a long axis > 2.0 cm and short axis >= 1.0 cm.
• Baseline FDG-PET scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites.
• Age 18 yrs or older.
• ECOG performance status of 0, 1 or 2.
• Eligible for high dose chemotherapy and ASCT.
• Resolution of toxicities from first-line therapy to a grade that in the opinion of the investigator does not contraindicate study participation.
• Signed written informed consent.

You may not qualify if…

• Previous cancer therapy for lymphoma, with the exception of first-line rituximab/ anthracycline- or anthracenedione-based chemotherapy, monotherapy rituximab prior to or combined with first-line chemotherapy, as maintenance therapy, and radiotherapy in a limited field or as a part of the first-line treatment plan.
• Any anti-cancer therapy, except limited field radiotherapy, within 2 weeks prior to start of study therapy.
• Planned post-randomization chronic glucocorticoid use (limited acute use is allowed and defined by the protocol) unless administered as therapy for mild COPD or asthma.
• Clinically significant cardiac disease, active or chronic infections, serious significant diseases, other cancer within last 5 years. History of significant cerebrovascular disease.
• Prior treatment with anti-CD20 monoclonal antibodies with the exception of rituximab.
• Abnormal/ inadequate WBC count, liver, and kidney function.
• Pregnant or lactating women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception during and up to 1 year following dosing completion.

Where it is running

• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Westwood, Kansas, United States
• GSK Investigational Site — Jackson, Mississippi, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Chaple Hill, North Carolina, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Providence, Rhode Island, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Capital Federal, Buenos Aires, Argentina
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — La Plata, Buenos Aires, Argentina
• GSK Investigational Site — Graz, Austria
• GSK Investigational Site — Innsbruck, Austria
• GSK Investigational Site — Linz, Austria
• GSK Investigational Site — Linz, Austria
• GSK Investigational Site — Salzburg, Austria
• GSK Investigational Site — Vienna, Austria
• GSK Investigational Site — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.