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Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia

NCT00003659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-10-24

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia.

Conditions

Interventions

BIOLOGICAL

filgrastim

Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.

BIOLOGICAL

rituximab

Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.

DRUG

cyclophosphamide

Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.

DRUG

fludarabine phosphate

Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Mark Adam Weiss, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003659 on ClinicalTrials.gov