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HuMax-CD20 in Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
Genmab
ClinicalTrials.gov Identifier:
NCT00093314
First received: October 6, 2004
Last updated: January 5, 2007
Last verified: January 2007
History of Changes
  Purpose

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
 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-Labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:

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:

  • Chronic Lymphocytic Leukemia
  • Circulating lymphocytes above a specific level
  • Circulating lymphocytes showing certain markers

Exclusion Criteria:

  • Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
  • Previous stem cell transplantation.
  • Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy.
  • HIV positivity.
  • Hepatitis B or hepatitis C.
  • Other cancerous diseases, except certain skin cancers and cervix cancer.
  • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
  • Participation in another trial with a different new drug 4 weeks prior to enrollment in study.
  • Current participation in any other clinical study.
  • Pregnant or breast-feeding women.
  • Women of childbearing age who are unable or unwilling to use adequate contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093314

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: NCT00093314     History of Changes
Other Study ID Numbers: Hx-CD20-402
Study First Received: October 6, 2004
Last Updated: January 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Genmab:
Chronic Lymphocytic Leukemia
B-cell Lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013