NIH Clinical Center, Research Study- Chronic lymphocytic leukemia (CLL/SLL)

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Chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) Clinical Trial

Researchers at the National Institutes of Health (NIH) are seeking volunteers with CLL and SLL to participate in an investigational treatment study with ibrutinib, short-course fludarabine, and pembrolizumab. Eligible volunteers must have either received treatment for CLL and relapsed OR have high-risk genetic changes, regardless of prior treatment. Volunteers will participate in the study for at least one year or longer and treatment may continue indefinitely.

Research participants at NIH receive care, treatment, and procedures at no cost. Travel may be reimbursed.

The study will be conducted in 3 phases:

• Phase 1 (12 weeks) – you will receive ibrutinib by mouth for four weeks and then fludarabine by infusion in addition to the ibrutinib for Wk 5 and Wk 9
• Phase 2 (2 years) – you will receive pembrolizumab by infusion, every 3 weeks
• Follow-up (after 2 years, 3 months) - the study team will decide if you should stop the ibrutinib or continue indefinitely

You may be eligible, if you:

• Have a diagnosis of active CLL or SLL, and meet one of the following criteria
• Have received treatment for CLL and progressed
• Have high-risk genetic changes, such as deletion 17p, TP53 mutation, NOTCH1 mutation, or complex cytogenics
• Have a special type of transformed CLL called Hodgkin lymphoma
• Are at least 18 years old
• Are not allergic to ibrutinib, fludarabine, or pembrolizumab
• Are HIV negative

During this study, you will:

• Have a physical exam and medical history
• Provide blood and urine samples
• Receive the study medications by mouth or by infusion
• Come to the NIH Clinical Center for a minimum of one year

The NIH Clinical Center is America’s Research Hospital and is located in Bethesda, Maryland, on the Metro red line (Medical Center stop).

To learn how to participate, contact:
NIH Clinical Center Office of Patient Recruitment
1-866-444-1132
(TTY for the deaf or hard of hearing 1-866-411-1010)
Online: https://go.usa.gov/xQ7RY 
NIH study #17-H-0118