Skip to main content
OpenTrials
Completed

NCT Number: NCT00220311

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine Phosphate (Fludara)

Drug

6 cycles (1 cycle: 5 treatment days every 28 days)

Other names: BAY86-4864

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.