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

NCT00220311 | Completed Phase 4

• 2 other identifiers: 30353090699
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Fludarabine Phosphate (Fludara)

Interventions

Fludarabine Phosphate (Fludara) DRUG

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

Also known as: BAY86-4864

Arm 1

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabine phosphate

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: December 4, 2013

Record last verified: 2013-12