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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00092274
Recruitment Status : Withdrawn (Acquired asset)
First Posted : September 27, 2004
Last Update Posted : April 21, 2015
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: HuMax-CD20 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2004
Primary Completion Date : January 2005
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ofatumumab
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Anti-cancer therapy
    2. Glucocorticosteroids unless less than 10 mg prednisolone/day
    3. 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092274


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
GlaxoSmithKline
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00092274     History of Changes
Other Study ID Numbers: Hx-CD20-001
First Posted: September 27, 2004    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: January 2005

Keywords provided by GlaxoSmithKline:
Follicular Lymphoma
Non Hodgkin´s Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Ofatumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs