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

Phase 4CompletedNCT00220311

Genzyme, a Sanofi Company10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Fludarabine Phosphate (Fludara)DRUG

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings

Time frame: Up to 6 treatment cycles (at about 6 months)

Duration of response and change of peripheral blood findings

Time frame: End of study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.