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HuMax-CD20 in Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HuMax-CD20
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Iowa, Hospitals and Clinics

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 6, 2004
Last Updated
April 20, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00093314
Brief Title
HuMax-CD20 in Chronic Lymphocytic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Withdrawn
Why Stopped
Acquired asset
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia, B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HuMax-CD20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Iowa, Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24443277
Citation
Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
Results Reference
derived
PubMed Identifier
20408846
Citation
Coiffier B, Losic N, Ronn BB, Lepretre S, Pedersen LM, Gadeberg O, Frederiksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Robak T, Petersen J. Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1-2 study. Br J Haematol. 2010 Jul;150(1):58-71. doi: 10.1111/j.1365-2141.2010.08193.x. Epub 2010 Apr 16.
Results Reference
derived
PubMed Identifier
18003886
Citation
Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Flensburg M, Petersen J, Robak T. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood. 2008 Feb 1;111(3):1094-100. doi: 10.1182/blood-2007-09-111781. Epub 2007 Nov 14.
Results Reference
derived

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HuMax-CD20 in Chronic Lymphocytic Leukemia

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