Overview

Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)

Status:
Completed
Trial end date:
2020-07-22
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn more about the characteristics of CLL, including genes and chromosome abnormalities and proteins expressed by the leukemia cells, which may help doctors predict if patients who receive standard treatment (fludarabine, cyclophosphamide, and rituximab) for the first time will experience a complete remission.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Criteria
Inclusion Criteria:

1. Patients will have a diagnosis of CLL, Small Lymphocytic Lymphoma (SLL), or CD20
positive low-grade lymphoproliferative disorder.

2. All patients with untreated Rai stage III-IV are eligible for this protocol. Prior
treatment with single-agent rituximab permitted. OR Patients with untreated Rai stage
0-II who meet one or more criteria for active disease as defined by the International
Working Group for CLL (IWCLL). Prior treatment with single-agent rituximab permitted.

3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0-3.

4. Patients must have adequate renal and hepatic function (creatinine <2mg%, bilirubin
<2mg%). Patients with renal or liver dysfunction due to organ infiltration by
lymphocytes may be eligible after discussion with the study chairman.

5. Patients may not receive other concurrent chemotherapy, radiotherapy, or
immunotherapy. Localized radiotherapy to an area not compromising bone marrow function
does not apply.

6. Patients must be 16 years of age or older.

7. Patients must sign informed consent indicating that they are aware of the
investigational nature of this study according to the policies of the MD Anderson
Cancer Center Institutional Review Board (MDACC IRB).

Exclusion Criteria:

N/A