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NCT00742144

Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

Completed Phase 1 Last updated 17 November 2017
What this trial tests

Phase 1 trial testing ofatumumab in Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular in 6 participants. Completed in 18 November 2009.

Timeline
19 September 2008
Primary endpoint
18 November 2009
18 November 2009

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date19 September 2008
Primary completion18 November 2009
Estimated completion18 November 2009
Sites3 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 79, any sex, with Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.

Publications & conference data

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

  1. Ofatumumab.
    Zhang B. · · 2009 · cited 55× · PMID 20068404 · DOI 10.4161/mabs.1.4.8895
  2. Phase I study of ofatumumab, a human anti-CD20 antibody, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
    Ogura M, Hatake K, Tobinai K, Uchida T, et al · · 2013 · cited 10× · PMID 23456745 · DOI 10.1093/jjco/hyt022

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Data sources for this page

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/NCT00742144.

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