NCT01014208: ORCHARRD

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

Completed Phase 3 Results posted Last updated 9 July 2015

What this trial tests

Phase 3 trial testing OFATUMUMAB + DHAP in Lymphoma, Large-Cell, Diffuse in 447 participants. Completed in 1 November 2014.

Timeline

1 March 2010

Primary endpoint
1 February 2014

1 November 2014

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	447
Start date	1 March 2010
Primary completion	1 February 2014
Estimated completion	1 November 2014
Sites	173 locations across United States, Argentina, Austria, Belgium, China, Czechia, Denmark, Estonia

Drugs / interventions tested

• OFATUMUMAB + DHAP — full drug profile →
• RITUXIMAB + DHAP — full drug profile →

Conditions studied

• Lymphoma, Large-Cell, Diffuse — all drugs for Lymphoma, Large-Cell, Diffuse →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Large-Cell, Diffuse. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free Survival as Assessed by Independent Reviewers
  Time frame: From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)
  Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease \[PD\]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel drug targets for personalized precision medicine in relapsed/refractory diffuse large B-cell lymphoma: a comprehensive review.
   Camicia R, Winkler HC, Hassa PO. · · 2015 · cited 137× · PMID 26654227 · DOI 10.1186/s12943-015-0474-2
2. Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20⁺ B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis.
   Luo C, Wu G, Huang X, Ma Y, et al · · 2021 · cited 42× · PMID 33547368 · DOI 10.1038/s41598-021-82841-w
3. Advances in Lipid-Based Nanoparticles for Cancer Chemoimmunotherapy.
   Wang T, Suita Y, Miriyala S, Dean J, et al · · 2021 · cited 33× · PMID 33918635 · DOI 10.3390/pharmaceutics13040520
4. Efficacy of Salvage Treatments in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Including Chimeric Antigen Receptor T-Cell Therapy: A Systematic Review and Meta-Analysis.
   Kim J, Cho J, Yoon SE, Kim WS, et al · · 2023 · cited 11× · PMID 36915243 · DOI 10.4143/crt.2022.1658
5. A systematic review of head-to-head trials of approved monoclonal antibodies used in cancer: an overview of the clinical trials agenda.
   Luo J, Nishikawa G, Prasad V. · · 2019 · cited 9× · PMID 31396700 · DOI 10.1007/s00432-019-02984-2