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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00046683 |
Purpose
This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.
| Condition | Intervention | Phase |
|---|---|---|
|
B Cell Chronic Lymphocytic Leukemia |
Drug: alemtuzumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia |
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| United States, Arizona | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, Florida | |
| Ft. Myers, Florida, United States | |
| Tampa, Florida, United States | |
| United States, Illinois | |
| Hines, Illinois, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| Paducah, Kentucky, United States | |
| United States, Louisiana | |
| Lafayette, Louisiana, United States | |
| United States, Mississippi | |
| Jackson, Mississippi, United States | |
| Tupelo, Mississippi, United States | |
| United States, Missouri | |
| Jefferson City, Missouri, United States | |
| Kansas City, Missouri, United States | |
| United States, Montana | |
| Billings, Montana, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, New York | |
| New Hyde Park, New York, United States | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| United States, South Dakota | |
| Sioux Falls, South Dakota, United States | |
| United States, Texas | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Norfolk, Virginia, United States | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00046683 History of Changes |
| Other Study ID Numbers: | CAM307 |
| Study First Received: | October 1, 2002 |
| Last Updated: | July 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Adult acute leukemia Adult chronic leukemia Childhood leukemia Campath Alemtuzumab |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Chlorambucil Alemtuzumab |
Campath 1G Antibodies, Neoplasm Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |