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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00220311

Enrollment

Registered

2005-09-22

Start date

2000-11-30

Completion date

2005-09-30

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

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.

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.

Interventions

DRUGFludarabine Phosphate (Fludara)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)	Up to 6 treatment cycles (at about 6 months)

Secondary

Measure	Time frame
Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings	Up to 6 treatment cycles (at about 6 months)
Duration of response and change of peripheral blood findings	End of study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026