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Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

NCT00794820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-05-08

Study results available
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Summary

Primary Objective:

* To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.

Secondary Objective:

* To evaluate remission duration and survival.

Conditions

Interventions

DRUG

Fludarabine Phosphate

25 mg/m\^2 by vein over 5-30 minutes daily for 3 days (days 2-4)

DRUG

Cyclophosphamide

250 mg/m\^2 by vein over 60 minutes daily for 3 days (days 2-4)

DRUG

Rituximab

375 mg/m\^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m\^2 on days 2-3

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Susan O'Brien, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00794820 on ClinicalTrials.gov