NCT00823719 is a Phase 2 clinical trial of ofatumumab + ICE in Lymphoma, Large-Cell, Diffuse, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00823719?

NCT00823719 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00823719?

Interventions in NCT00823719: ofatumumab + ICE, ofatumumab + DHAP.

What condition does NCT00823719 study?

NCT00823719 studies Lymphoma, Large-Cell, Diffuse.

Is NCT00823719 still recruiting?

NCT00823719 is currently completed. Last updated 7 March 2013.

Are results published for NCT00823719?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-03-07 · How we verify

NCT00823719

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

Completed Phase 2 Results posted Last updated 7 March 2013

What this trial tests

Phase 2 trial testing ofatumumab + ICE in Lymphoma, Large-Cell, Diffuse in 61 participants. Completed in 1 September 2011.

Timeline

1 May 2009

Primary endpoint
1 July 2011

1 September 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	1 May 2009
Primary completion	1 July 2011
Estimated completion	1 September 2011

Drugs / interventions tested

ofatumumab + ICE — full drug profile →
ofatumumab + 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.

Number of Participants With Overall Response (OR), as Assessed by the Investigator
Time frame: From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3
Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target

Sponsor's own description

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.

Publications & conference data

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

Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma.
Matasar MJ, Czuczman MS, Rodriguez MA, Fennessy M, et al · · 2013 · cited 52× · PMID 23692856 · DOI 10.1182/blood-2012-12-472027
Investigational immunotherapeutics for B-cell malignancies.
Quintás-Cardama A, Wierda W, O'Brien S. · · 2010 · cited 19× · PMID 20048186 · DOI 10.1200/jco.2009.22.8254
Novel therapies for aggressive B-cell lymphoma.
Foon KA, Takeshita K, Zinzani PL. · · 2012 · cited 14× · PMID 22536253 · DOI 10.1155/2012/302570
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

Verify or expand the search:

Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00823719 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 7 March 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00823719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing