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

This study has been withdrawn prior to enrollment.
(Acquired asset)
Information provided by:
GlaxoSmithKline Identifier:
First received: September 22, 2004
Last updated: April 20, 2015
Last verified: January 2005
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
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Enrollment: 0
Study Start Date: September 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00092274

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00092274     History of Changes
Other Study ID Numbers: Hx-CD20-001
Study First Received: September 22, 2004
Last Updated: April 20, 2015

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

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017