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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00562965 |
This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.
Condition | Intervention | Phase |
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Lymphoma, Follicular |
Drug: inotuzumab ozogamicin Drug: rituximab Drug: cyclophosphamide, vincristine and prednisone/prednisolone (R-CVP) Drug: fludarabine, Novantrone (mitoxantrone) and dexamethasone (R-FND) |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator's Choice Therapy in Subjects With Relapsed or Refractory, CD22-Positive, Follicular B-Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 978 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | September 2014 |
Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental | Drug: inotuzumab ozogamicin Drug: rituximab |
B: Active Comparator | Drug: rituximab Drug: cyclophosphamide, vincristine and prednisone/prednisolone (R-CVP) Drug: fludarabine, Novantrone (mitoxantrone) and dexamethasone (R-FND) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3129K4-3301 |
Study First Received: | November 21, 2007 |
Last Updated: | August 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00562965 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Dexamethasone Prednisone Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Prednisolone acetate Cyclophosphamide Hormones Follicular Lymphoma Antibodies, Monoclonal Lymphoma, Small Cleaved-cell, Diffuse |
Lymphoma, B-Cell Analgesics Alkylating Agents Lymphoma Dexamethasone acetate Immunoglobulins Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Methylprednisolone acetate Vincristine Fludarabine monophosphate Glucocorticoids Immunosuppressive Agents |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Cyclophosphamide Hormones Antibodies, Monoclonal Sensory System Agents Therapeutic Uses Analgesics |
Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Gastrointestinal Agents Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Autonomic Agents Prednisolone |