NCT00622388

Brief Summary

The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 8, 2011

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 24, 2015

Status Verified

January 1, 2015

Enrollment Period

2.4 years

First QC Date

February 13, 2008

Results QC Date

August 4, 2011

Last Update Submit

July 2, 2015

Conditions

Lymphoma, Large-Cell, Diffuse

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Objective Response

    Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.

    6-month period from start of treatment (up to Week 24)

  • Number of Participants Classified as Responders and Non-responders for Objective Response

    According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD.

    6-month period from start of treatment (up to Week 24)

Secondary Outcomes (13)

  • Duration of Response

    From date of start of treatment to 2 years or withdrawal

  • Progression-free Survival (PFS)

    From date of start of treatment to 2 years or withdrawal

  • Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy

    From date of start of treatment to 5 years or withdrawal

  • Overall Survival (OS)

    From date of start of treatment to 5 years or withdrawal

  • Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18

    Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)

  • +8 more secondary outcomes

Study Arms (1)

Ofatumumab

EXPERIMENTAL

8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg

Drug: Ofatumumab

Interventions

OfatumumabDRUG

8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

Ofatumumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with DLBCL
  • and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
  • and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

London, London, EC1M 6BQ, United Kingdom

Location

Related Publications (1)

  • Coiffier B, Radford J, Bosly A, Martinelli G, Verhoef G, Barca G, Davies A, Decaudin D, Gallop-Evans E, Padmanabhan-Iyer S, Van Eygen K, Wu KL, Gupta IV, Lin TS, Goldstein N, Jewell RC, Winter P, Lisby S; 415 study investigators. A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma. Br J Haematol. 2013 Nov;163(3):334-42. doi: 10.1111/bjh.12537. Epub 2013 Aug 23.

    PMID: 24032456DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 25, 2008

Study Start

December 1, 2007

Primary Completion

May 1, 2010

Study Completion

August 1, 2014

Last Updated

July 24, 2015

Results First Posted

September 8, 2011

Record last verified: 2015-01

Locations

GB(1)