Ofatumumab vs. Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBCL (ORCHARDD Trial/ Phase III)

What is the purpose of this trial?

As rituximab-based regimens have become standard first-line treatment in CD20 positive DLBCL, the efficacy of rituximab combined with salvage chemotherapy in the secondline 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.

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 or grade 3b FL subjects progressing, relapsing or with persistent lymphoma after first-line treatment with rituximab combined with an anthracycline- or anthracenedione-based chemotherapy regimen.

Primary objective:

• To 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).

Secondary objectives. To evaluate the following in subjects receiving O-chemo compared to subjects receiving R-chemo:

• Overall and complete response rate after salvage chemoimmunotherapy.

• Overall and complete response rate three months after ASCT.

• Event-free survival.

• Overall survival.

• Number of subjects with inadequate mobilisation of autologous stem cells (<2.0 million CD34+ cells/kg) prior to administration of high dose therapy (HDT).

• Number of subjects completing ASCT.

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Participation Guidelines

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Sponsor:

GlaxoSmithKline

Dates:

September 2012

Last Updated:

Study HIC#:

1202009794

Clinicaltrials.gov ID: Yale8885570