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

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ClinicalTrials.gov Identifier: NCT00220311
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
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 or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Drug: Fludarabine Phosphate (Fludara) Phase 4

Detailed Description:
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2000
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005


Arm Intervention/treatment
Experimental: Arm 1 Drug: Fludarabine Phosphate (Fludara)
6 cycles (1 cycle: 5 treatment days every 28 days)
Other Name: BAY86-4864




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings [ Time Frame: Up to 6 treatment cycles (at about 6 months) ]
  2. Duration of response and change of peripheral blood findings [ Time Frame: End of study ]


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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220311


Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company

Additional Information:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00220311     History of Changes
Other Study ID Numbers: 303530
90699
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Thrombocytopenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Blood Platelet Disorders
Hematologic Diseases
Fludarabine
Fludarabine phosphate
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents