Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center OSI Pharmaceuticals |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00254410 |
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated filgrastim, will improve the response to treatment, and increase the time this response lasts, for patients with previously untreated CLL. The safety of this combination will also be studied.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia |
Drug: Fludarabine Drug: Cyclophosphamide Drug: Mitoxantrone Drug: Rituximab Drug: Filgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of the Activity and Safety of Fludarabine, Cyclophosphamide, and Mitoxantrone Plus Rituximab (FCM-R) With Pegfilgrastim (Neulasta) as Frontline Therapy for Patients < 70 Years With Chronic Lymphocytic Leukemia |
Enrollment: | 31 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Fludarabine Cyclophosphamide Mitoxantrone Rituximab Pegylated Filgrastim
|
Drug: Fludarabine
Fludarabine 25mg/m2/day 2,3,4 i.v. 5-30 mins.
Drug: Cyclophosphamide
Cyclophosphamide 250mg/m2/day 2,3,4 i.v. 5-30 mins.
Drug: Mitoxantrone
Mitoxantrone 6mg/m2/day 2 i.v. 30-60 mins.
Drug: Rituximab
Rituximab 375mg/m2/day 1 i.v. 2-6 hours
Drug: Filgrastim
Pegylated Filgrastim - 6mg on day 4,s.c.
|
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T. M. D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Stefan H Faderl, MD | U.T. M. D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Dr. Stefan Faderl, MD/Associate Professor ) |
Study ID Numbers: | 2005-0106 |
Study First Received: | November 14, 2005 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00254410 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic Lymphocytic Leukemia Untreated Fludarabine Fludara Cyclophosphamide Cytoxan |
Mitoxantrone Novantrone Rituximab Rituxan Pegylated Filgrastim Neupogen |
Antimetabolites Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Cyclophosphamide Fludarabine monophosphate Immunosuppressive Agents Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Leukemia, Lymphocytic, Chronic, B-Cell Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Mitoxantrone Fludarabine Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Alkylating Agents |
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Sensory System Agents Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Analgesics Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Peripheral Nervous System Agents Fludarabine Mitoxantrone Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell |