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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: | NCT00086580 |
This is a Phase III, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of Fludara plus alemtuzumab versus Fludara alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.
Condition | Intervention | Phase |
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B-Cell Lymphocytic Leukemia |
Biological: alemtuzumab (Campath, MabCampath); FluCAM [Fludara + Campath] Biological: fludarabine phosphate (Fludara) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludara Plus Alemtuzumab (Campath, MabCampath) Versus Fludara Alone in Patients With B-Cell Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 335 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
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ARM 1 - Combination Arm(Fludara + Campath): Active Comparator |
Biological: alemtuzumab (Campath, MabCampath); FluCAM [Fludara + Campath]
Phase A: Escalating Doses of Campath Alone (Arm 1): Day 1 Campath 3 mg IV over 2 hours. Day 2 Campath 10 mg IV over 2 hours if 3 mg as tolerated, else repeat 3 mg daily until tolerated. Day 3 Campath 30 mg IV over 2 hours if 10 mg was tolerated, else repeat 10 mg daily until tolerated. Phase B: FluCAM (Fludara + Campath) (Arm 1): For Cycle 1 Fludara is administered at 30 mg/m2 over 30 minutes IV, Day 1, 2, 3 followed immediately (within 1 hour) by Campath 30 mg IV over 2 hours, Day 1, 2, 3. A similar schedule is set for Cycles 2 through 6; lengths of the infusions vary. |
ARM 2 - Fludara Alone: Active Comparator |
Biological: fludarabine phosphate (Fludara)
For patients randomized to Arm 2, Fludara is administered at a dose of 25 mg/m2 intravenously (IV) over 15 to 30 minutes daily for 5 consecutive days (days 1 through 5) every 28 days (per package instructions). Each 28-day period is 1 cycle. The dose of Fludara will be based on the patient's BSA as calculated at the beginning of each cycle
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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:
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CAM314 |
Study First Received: | July 6, 2004 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00086580 |
Health Authority: | United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Bulgaria: Bulgarian Drug Agency or Ministry of Health; Canada: Health Canada; Croatia: Ministry of Health and Social Care; Czech Republic: State of Institute for Drug control; France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) - French health Products Safety Agency; Germany: Feeral Institute for Drugs and Medical Devices; Greece: National Organization for Medicines; Italy: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal products or Main Pharmaceutical Inspectorate; Portugal: National Pharmacy and Medicines Institute (IFARMED); Romania: National Medicines Agency; Russian Federation: Ministry of Health and Social Development of the Russian Federation; Sweden: Medical Products Agency (MPA); Ukraine: State Pharmacological Center - Ministry of Health |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Alemtuzumab Leukemia, B-cell, chronic Fludarabine Fludarabine monophosphate Lymphoproliferative Disorders Leukemia, B-Cell |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors |
Immune System Diseases Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |