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CompletedNCT00220311Updated Dec 4, 2013

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

A Phase 4 interventional study of Fludarabine Phosphate (Fludara) in Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Genzyme, a Sanofi Company. Completed. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-04.

Sponsored by Genzyme, a Sanofi Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
15 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia, Lymphocytic, Chronic, B-Cell
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Fludarabine Phosphate (Fludara)

Interventions

  • DrugFludarabine Phosphate (Fludara)

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

    Also known as: BAY86-4864

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00220311
Lead sponsor
Genzyme, a Sanofi Company
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Nov 2000
Primary completion
Sep 2005
Completion
Sep 2005
Last update
Dec 4, 2013

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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