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Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

NCT01082939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-02-20

Study results available
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Summary

The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy.

Primary Objectives:

Evaluate the therapeutic efficacy, including the complete remission (CR), nodular partial remission (NPR), and partial remission (PR) rates (overall response) of combined cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) in previously treated patients with Chronic Lymphocytic Leukemia (CLL).

Second Objectives:

* Assess the toxicity profile of CFAR in previously treated patients with CLL.
* Monitor for infection and determine incidence and etiology of infection including cytomegalovirus in patients treated with CFAR.
* Evaluate molecular remission by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responding patients treated with CFAR.
* Assess immune parameters, including pretreatment, during treatment, and post-treatment blood T-cell counts and subset distribution and serum immunoglobulin levels in patients treated with CFAR.

Conditions

Interventions

DRUG

Fludarabine

25 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.

DRUG

Cyclophosphamide

250 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.

DRUG

Alemtuzumab

30 mg IV on Days 1, 3 and 5 over 2-4 hours; repeated every four weeks for a total of 6 planned cycles.

DRUG

Rituximab

Cycle 1 (Week 1): 375 mg/m\^2/day IV on Day 2 over 4- 6 hours Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV on Day 2 over 4- 6 hours

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • William G. Wierda, MD, PhD, BS · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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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 NCT01082939 on ClinicalTrials.gov