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

Phase 3
18 Years
Open (Enrolling)
Lymphoma, Large-Cell, Diffuse

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Trial Information

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

As rituximab-based regimens have become standard first-line treatment in CD20 positive
DLBCL, the efficacy of rituximab combined with salvage chemotherapy in the second-line
setting has decreased and there is a need for new therapies in patients progressing or
relapsing after first-line rituximab-based therapy. Replacement of rituximab with ofatumumab
in the second-line setting, following progression/relapse after first-line
rituximab-containing regimens, offers the potential to overcome relative or complete
rituximab resistance and thus improve response rates, the ability to proceed to
consolidative HDT/ASCT, and overall survival.

Inclusion Criteria:

- Subjects with CD20 positive DLBCL or grade 3b follicular lymphoma (FL) at original

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the progression-free survival (PFS) in subjects receiving ofatumumab in addition to salvage chemotherapy (O-chemo) compared to subjects receiving rituximab in addition to salvage chemotherapy (R-chemo)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

March 2010

Completion Date:

November 2018

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • Polish Lymphoma Research Group
  • Japan Clinical Oncology Group
  • refractory
  • DHAP
  • The All Ireland Cooperative Oncology Research Group
  • Oncology
  • Grupo Espanol de Linfomas
  • ofatumumab
  • Salvage chemotherapy
  • DVD
  • Nordic Lymphoma Group
  • rituximab
  • Autologous Stem Cell Transplant
  • National Cancer Research Institute Lymphoma Clinical Studies Group
  • safety
  • Dutch-Belgian Cooperative Trial Group for Hematology-Oncology
  • Genmab
  • relapsed
  • efficacy
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteHartford, Connecticut  06106
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteSeattle, Washington  98133