A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
NCT00220311 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2013-12-04
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
Interventions
- DRUG
-
Fludarabine Phosphate (Fludara)
6 cycles (1 cycle: 5 treatment days every 28 days)
Sponsors & Collaborators
-
Genzyme, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Genzyme, a Sanofi Company
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-11-30
- Primary Completion
- 2005-09-30
- Completion
- 2005-09-30
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