A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00220311

Purpose

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
Chronic Lymphocytic Leukemia	Drug: Fludarabine Phosphate (Fludara, BAY86-4864)	Phase IV

MedlinePlus related topics: Anemia Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Fludarabine Fludarabine monophosphate

U.S. FDA Resources

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 Fludarabine Phosphate Administered in 6 Treatment Cycles (1 Cycle: 5 Treatment Days Every 28 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

Further study details as provided by Bayer:

Primary Outcome Measures:

Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months) [ Time Frame: Up to 6 treatment cycles (at about 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings [ Time Frame: Up to 6 treatment cycles (at about 6 months) ] [ Designated as safety issue: No ]
Duration of response and change of peripheral blood findings [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	November 2000
Study Completion Date:	July 2005

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Fludarabine Phosphate (Fludara, BAY86-4864) 6 cycles (1 cycle: 5 treatment days every 28 days)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	15 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed CLL
Patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
Patients who have not received cancer chemotherapy or radiotherapy

Exclusion Criteria:

Patients with apparent infections (including viral infections)
Patients with serious complications (heart, liver, or kidney disease, etc.)
Patients with a serious bleeding tendency (e.g., DIC)
Patients with serious CNS symptoms
Patients with fever >= 38°C (excluding tumor fever)
Patients with interstitial pneumonia or pulmonary fibrosis
Patients with active multiple cancers
Patients receiving other investigational products within 6 months before registration in this study
Patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
Women who are pregnant, of childbearing potential, or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220311

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Yakuhin Ltd. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	90699, 303530
Study First Received:	September 21, 2005
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00220311 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Antimetabolites
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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 06, 2009