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

Completed · Phase 1/Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT01096992

Run by

M.D. Anderson Cancer Center

People needed

51

Starts

2010-04-19

Expected to finish

2017-03-31

Last updated by the study team

2019-09-25

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be previously treated
• Patients must have an indication for treatment by 2008 IWCLL Criteria
• Age >/= 16 years
• Zubrod performance status </= 2
• Adequate renal and hepatic function as indicated by all the following: a. serum creatinine </= 2 mg/dL AND; b. alanine aminotransferase (ALT) </= 2.5 times upper limit of normal AND; c. total bilirubin </= 2.5 times upper limit of normal
• Patients must give written informed consent
• Patients of childbearing potential must be willing to practice birth control during the study

You may not qualify if…

• Pregnant or breast-feeding females
• Significant co-morbidity indicated by major organ system dysfunction
• Active, uncontrolled infection, including active hepatitis
• Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
• 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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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