Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Status:
Completed
Trial end date:
2021-02-19
Target enrollment:
Participant gender:
Summary
Background:
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers often
treated with the drug ibrutinib. For some people, ibrutinib stops working. Researchers want
to see if adding another drug can help.
Objective:
To test how people with ibrutinib-resistant CLL respond to duvelisib.
Eligibility:
People ages 18 and older with CLL or SLL that is no longer responding to ibrutinib or has
developed mutations that could stop it from working
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Heart tests
- Blood and urine tests
- CT scan. For this, participants will have a dye injected into a vein. They will lie in a
machine that takes pictures of the body.
- Bone marrow biopsy. For this, a needle injected into the participant s bone will remove
marrow.
- Optional lymph node biopsy. For this, the participant s whole lymph node or part of it
will be removed through the skin.
- Optional lymphapheresis. For this, the participant s blood is removed through a vein in
one arm, the white blood cells separated out, and the blood returned through a vein in
the other arm.
Participants will take duvelisib twice daily by mouth. They will continue ibrutinib at their
current dose for the first 6 months. They will continue to take duvelisib until their CLL/SLL
stops responding or they develop intolerable side effects.
Participants will take an antibiotic and antiviral medication. They may take steroids.
Participants will have blood tests every 2 weeks during the first 2 months.
Participants will have monthly follow-up visits during the first 6 months and every 3 months
thereafter. These will include repeats of some of the screening tests.