- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093314
HuMax-CD20 in Chronic Lymphocytic Leukemia
April 20, 2015 updated by: GlaxoSmithKline
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
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa, Hospitals and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
October 6, 2004
First Submitted That Met QC Criteria
October 7, 2004
First Posted (Estimate)
October 8, 2004
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hx-CD20-402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Lymphocytic Leukemia
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National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingLeukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | Leukemia, Chronic Lymphatic | B-Cell Chronic Lymphocytic Leukemia | Leukemia, Lymphocytic, Chronic | B-Lymphocytic Leukemia, Chronic | Leukemia, Chronic Lymphocytic, B-Cell | Lymphocytic Leukemia, Chronic, B Cell | Lymphocytic Leukemia...United States
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National Cancer Institute (NCI)TerminatedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)TerminatedLeukemia | B-cell Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Celgene CorporationTerminatedChronic Lymphocytic Leukemia | B-cell Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
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Roswell Park Cancer InstituteWithdrawnRefractory Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic Leukemia
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Mayo ClinicNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia and other conditionsUnited States
Clinical Trials on HuMax-CD20
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedChronic Lymphocytic LeukemiaUnited States
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GlaxoSmithKlineWithdrawnLymphoma, FollicularUnited States
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Massachusetts General HospitalGlaxoSmithKline; Dana-Farber Cancer Institute; Beth Israel Deaconess Medical...CompletedFollicular Lymphoma | Marginal Zone Lymphoma | Small Lymphocytic LymphomaUnited States
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GlaxoSmithKlineGenmabCompletedLeukaemia, Lymphocytic, ChronicSweden
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Emory UniversityNovartisTerminatedRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Recurrent Chronic Lymphocytic Leukemia | Refractory Small Lymphocytic LymphomaUnited States
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National Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Recurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic LeukemiaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedFatigue | Thrombocytopenia | Fever | Chronic Lymphocytic Leukemia | Lymphadenopathy | Small Lymphocytic Lymphoma | Hypogammaglobulinemia | Lymphocytosis | Night Sweats | ParaproteinemiaUnited States
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI); GlaxoSmithKline; Millennium Pharmaceuticals,...TerminatedRecurrent Adult Diffuse Large Cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Mantle Cell LymphomaUnited States
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Januario Castro, M.D.GlaxoSmithKlineCompleted
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); GlaxoSmithKlineTerminatedWaldenström MacroglobulinemiaUnited States