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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00220311
First received: September 21, 2005
Last updated: December 2, 2013
Last verified: December 2013
  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
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: Fludarabine Phosphate (Fludara)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Fludarabine Phosphate (Fludara)
6 cycles (1 cycle: 5 treatment days every 28 days)
Other Name: BAY86-4864

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.

  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
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00220311     History of Changes
Other Study ID Numbers: 303530, 90699
Study First Received: September 21, 2005
Last Updated: December 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 15, 2014