HuMax-CD20 in Chronic Lymphocytic Leukemia

This study has been withdrawn prior to enrollment.
(Acquired asset)
Information provided by:
GlaxoSmithKline Identifier:
First received: October 6, 2004
Last updated: April 20, 2015
Last verified: January 2007

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:

Further study details as provided by GlaxoSmithKline:

Enrollment: 0
Study Start Date: October 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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: NCT00093314

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00093314     History of Changes
Other Study ID Numbers: Hx-CD20-402
Study First Received: October 6, 2004
Last Updated: April 20, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on October 08, 2015