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| Sponsored by: |
Genmab |
| Information provided by: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00349349 |
Purpose
The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.
| Condition | Intervention | Phase |
|
B-Cell Chronic Lymphocytic Leukemia |
Drug: ofatumumab |
Phase III |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Fludarabine Fludarabine monophosphate Tositumomab Alemtuzumab Campath Ofatumumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Single-Arm, International, Multi-Center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-Cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations |
Show 60 Study Locations |
| Genmab |
| Study Chair: | Anders Österborg, Professor | Karolinska Hospital, Stockholm, Sweden |
| Study Chair: | William Wierda, Asst. Prof. | M.D. Anderson Cancer Center, Houston, Texas, US |
More Information
| Study ID Numbers: | Hx-CD20-406 |
| First Received: | July 6, 2006 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00349349 |
| Health Authority: | United States: Food and Drug Administration |
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