Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00220311 |
The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Lymphocytic, Chronic, B-Cell |
Drug: Fludarabine Phosphate (Fludara, BAY86-4864) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-Consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia |
Enrollment: | 10 |
Study Start Date: | November 2000 |
Study Completion Date: | September 2005 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: Fludarabine Phosphate (Fludara, BAY86-4864)
6 cycles (1 cycle: 5 treatment days every 28 days)
|
This study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Ages Eligible for Study: | 15 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Yakuhin Ltd. ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 90699, 303530 |
Study First Received: | September 21, 2005 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00220311 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Antimetabolites Anti-Infective Agents Vidarabine Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Hematologic Diseases Blood Platelet Disorders Anemia Fludarabine monophosphate Antiviral Agents |
Immunosuppressive Agents Thrombocytopathy Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia Thrombocytopenia Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic |
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Vidarabine Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia Thrombocytopenia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Blood Platelet Disorders Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Lymphoproliferative Disorders Leukemia, B-Cell |