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

September 21, 2005
December 2, 2013
November 2000
September 2005   (final data collection date for primary outcome measure)
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 ]
Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)
Complete list of historical versions of study NCT00220311 on ClinicalTrials.gov Archive Site
  • 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 ]
  • -Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
  • Duration of response and change of peripheral blood findings
Not Provided
Not Provided
 
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: Fludarabine Phosphate (Fludara)
6 cycles (1 cycle: 5 treatment days every 28 days)
Other Name: BAY86-4864
Experimental: Arm 1
Intervention: Drug: Fludarabine Phosphate (Fludara)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2005
September 2005   (final data collection date for primary outcome measure)

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
Both
15 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00220311
303530, 90699
No
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP