Overview

Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)

Status:
Completed

Trial end date:
2017-03-31

Target enrollment:
0

Participant gender:
All

Summary

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Bendamustine Hydrochloride
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine

Criteria

Inclusion Criteria:

1. Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be
previously treated

2. Patients must have an indication for treatment by 2008 IWCLL Criteria

3. Age >/= 16 years

4. Zubrod performance status
5. Adequate renal and hepatic function as indicated by all the following: a. serum
creatinine limit of normal AND; c. total bilirubin
6. Patients must give written informed consent

7. Patients of childbearing potential must be willing to practice birth control during
the study

Exclusion Criteria:

1. Pregnant or breast-feeding females

2. Significant co-morbidity indicated by major organ system dysfunction

3. Active, uncontrolled infection, including active hepatitis

4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura
(ITP)

5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy,
radiotherapy, high-dose corticosteroid therapy (Prednisone >/ 60 mg daily or
equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with
this trial