HuMax-CD20 in Chronic Lymphocytic Leukemia

This study has been completed.

First Received: October 6, 2004 Last Updated: January 5, 2007 History of Changes

Sponsored by:	Genmab
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00093314

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Ofatumumab

U.S. FDA Resources

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

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

Keywords provided by Genmab:

Chronic Lymphocytic Leukemia
B-cell Lymphoma

Study placed in the following topic categories:

Leukemia, Lymphoid
Immunoproliferative Disorders
Lymphoma, B-Cell
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Antibodies

B-cell Lymphomas
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on August 13, 2009