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

Genzyme

Status and phase

Completed

Phase 4

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Treatments

Drug: Fludarabine Phosphate (Fludara)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00220311

303530

90699

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

15 to 80 years old

Volunteers

No 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