Overview

CFAR Study in Patients With Chronic Lymphocytic Leukemia

Status:
Completed

Trial end date:
2011-07-01

Target enrollment:
0

Participant gender:
All

Summary

Primary Objective: 1. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with <5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a historic group of patients treated with the combination fludarabine, cyclophosphamide, and rituximab (FCR). Second Objectives: 1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. 2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responders treated with CFAR. 3. Assess immune parameters including blood T cell counts and subset distribution and serum immunoglobulin levels pretreatment, during treatment, and post-treatment in patients treated with CFAR.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Bayer

Treatments:

Alemtuzumab
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine

Criteria

Inclusion Criteria:

- All patients must have a diagnosis of CLL by immunophenotyping and flow cytometry
analysis of blood or bone marrow and be previously untreated.

- All patients must be younger than 70 years and have a serum beta-2 microglobulin of
>/= 4.0mg/L.

- All patients with Rai stage III-IV are eligible for treatment on this protocol. - OR -
All patients with Rai stage 0-II who meet one or more indication for treatment as
defined by the NCI-sponsored Working Group are eligible for treatment on this
protocol.

- All patients must have a Zubrod performance status of 0-3.

- All patients must have adequate renal and hepatic function (serum creatinine 2mg/dL; total bilirubin organ infiltration by lymphocytes may be eligible after discussion with the Principle
Investigator and appropriate dose adjustment considered.

- Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy.
Localized radiotherapy to an area not compromising bone marrow function does not
apply, nor do hematopoietic growth factors such as erythropoietin, Granulocyte
colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony Stimulating Factor
(GM-CSF), etc.

- Patients must not have untreated or uncontrolled life-threatening infection.

- Patients must sign informed consent.

Exclusion Criteria:

Patients older than 70 years.