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Sponsors and Collaborators: |
Genzyme Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00328198 |
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered CAMPATH as therapy for patients with relapsed or refractory B-CLL who have been previously treated.
Condition | Intervention | Phase |
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B-Cell Chronic Lymphocytic Leukemia (B-CLL) |
Biological: Alemtuzumab (CAMPATH, MabCampath) Biological: alemtuzumab (Campath, MabCampath) Biological: alemtuzumab (Campath® / MabCampath®) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 85 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
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Part 1 - Arm 1: Experimental
Campath with dose escalation
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Biological: Alemtuzumab (CAMPATH, MabCampath)
Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks
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Part 1 - Arm 2: Experimental
Campath without dose escalation
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Biological: alemtuzumab (Campath, MabCampath)
Campath treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks
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part 2: Experimental
Campath either with escalation or without escalation depending on the outcome of Part 1
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Biological: alemtuzumab (Campath® / MabCampath®)
An assigned review panel will review the data from part 1 to determine whether escalation or no escalation is the recommended schedule. All patients will then be enrolled into the recommended schedule (arm). CAMPATH is to be administered in a supervised medical setting on an outpatient basis for the first three weeks. After which some study centers may allow a home administration option where CAMPATH may be administered by patient or care giver if patients meet conditions specified in the protocol guidelines for home administration.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | Medinfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | Medinfo@genzyme.com |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | CAM203 |
Study First Received: | May 18, 2006 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00328198 |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Public Service: Health, Food Chaine Safety, and Environment; Czech Republic: State Institute for Drug Control; France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFDDAPS) - French Health Products Safety Agency; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; United Kingdom: MRHA |
CAMPATH Alemtuzumab Leukemia MabCampath Chronic Subcutaneous |
CLL C-CLL Relapsed Refractory Chronic Lymphocytic Leukemia |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |