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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
History of Changes
  Purpose

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


Condition Intervention Phase
Lymphoma, Follicular
 Drug: HuMax-CD20
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Genmab:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092274

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

No publications provided by Genmab

Additional 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
Study First Received: September 22, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Genmab:
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

ClinicalTrials.gov processed this record on May 23, 2013