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Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2004
Shorter than P25 for phase_1
1 active site
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 22, 2004
CompletedFirst Posted
Study publicly available on registry
September 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedApril 21, 2015
January 1, 2005
4 months
September 22, 2004
April 20, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Relapsed or refractory follicular lymphoma grade I-II
- Tumor verified to be CD20 positive
- CT scan showing demarcated lesions
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Related Publications (2)
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.
PMID: 24443277DERIVEDHagenbeek 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.
PMID: 18390837DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 22, 2004
First Posted
September 27, 2004
Study Start
September 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
April 21, 2015
Record last verified: 2005-01