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

This study has been completed.
Sponsor:
Information provided by:
Genmab
ClinicalTrials.gov Identifier:
NCT00092274
First received: September 22, 2004
Last updated: June 23, 2005
Last verified: January 2005

September 22, 2004
June 23, 2005
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Complete list of historical versions of study NCT00092274 on ClinicalTrials.gov Archive Site
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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

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

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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Follicular
Drug: HuMax-CD20
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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. Epub 2008 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00092274
Hx-CD20-001
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Genmab
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Genmab
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP