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Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

Primary Purpose

Lymphoma, Follicular

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HuMax-CD20
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Follicular focused on measuring Follicular Lymphoma, Non Hodgkin´s Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Relapsed or refractory follicular lymphoma grade I-II Tumor verified to be CD20 positive CT scan showing demarcated lesions Exclusion Criteria: Previous treatment with rituximab resulting in less than partial response Previous radioimmunotherapy Previous stem cell transplantation Received the following treatments within 4 weeks prior to entering this study: Anti-cancer therapy Glucocorticosteroids unless less than 10 mg prednisolone/day Radiotherapy Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial HIV positivity Hepatitis B or hepatitis C Uncontrolled or chronic bacterial, fungal or viral infection Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases WHO performance status of 3 or 4 If you are participating in another trial with a different new drug 4 weeks before you enter this trial Current participation in any other clinical study Pregnant or breast-feeding women Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial

Sites / Locations

  • University of Iowa Hospitals and Clinics

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 22, 2004
Last Updated
April 20, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00092274
Brief Title
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Official Title
An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Withdrawn
Why Stopped
Acquired asset
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular
Keywords
Follicular Lymphoma, Non Hodgkin´s Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HuMax-CD20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory follicular lymphoma grade I-II Tumor verified to be CD20 positive CT scan showing demarcated lesions Exclusion Criteria: Previous treatment with rituximab resulting in less than partial response Previous radioimmunotherapy Previous stem cell transplantation Received the following treatments within 4 weeks prior to entering this study: Anti-cancer therapy Glucocorticosteroids unless less than 10 mg prednisolone/day Radiotherapy Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial HIV positivity Hepatitis B or hepatitis C Uncontrolled or chronic bacterial, fungal or viral infection Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases WHO performance status of 3 or 4 If you are participating in another trial with a different new drug 4 weeks before you enter this trial Current participation in any other clinical study Pregnant or breast-feeding women Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24443277
Citation
Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
Results Reference
derived
PubMed Identifier
18390837
Citation
Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008 Jun 15;111(12):5486-95. doi: 10.1182/blood-2007-10-117671. Epub 2008 Apr 4.
Results Reference
derived

Learn more about this trial

Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

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