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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00113048 |
This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.
Condition | Intervention | Phase |
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Hematologic Malignancies |
Drug: CAMPATH (alemtuzumab) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Duluth, Minnesota, United States, 55806 | |
United States, North Carolina | |
Durham, North Carolina, United States, 27710 |
Study Director: | Medical Monitor | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CAM111 |
Study First Received: | June 3, 2005 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00113048 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CD52 Expressing Hematologic Malignancies |
Hematologic Neoplasms Hematologic Diseases Alemtuzumab |
Neoplasms Neoplasms by Site Hematologic Neoplasms Antineoplastic Agents |
Hematologic Diseases Therapeutic Uses Alemtuzumab Pharmacologic Actions |