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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00311129 |
The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma
Condition | Intervention | Phase |
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Lymphoma, Low-Grade |
Drug: Fludarabine phosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma |
Enrollment: | 41 |
Study Start Date: | December 2005 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Fludarabine phosphate
Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
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The 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: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Yakuhin Ltd. ( Therapeutic Area Head ) |
Study ID Numbers: | 91456, 309123 |
Study First Received: | March 31, 2006 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00311129 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Antimetabolites Vidarabine Immunoproliferative Disorders Immunologic Factors Rituximab Fludarabine monophosphate Immunosuppressive Agents |
Antiviral Agents Lymphatic Diseases Fludarabine Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Antimetabolites Anti-Infective Agents Vidarabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs |
Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Fludarabine Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |