PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Status:
Active, not recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
Background:
- Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or
lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood
cells that hurt the immune system and make it more difficult to fight infections. These
cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are
over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL.
They may have other health problems that make chemotherapy difficult. In addition,
individuals who have a genetic abnormality called 17p deletion also do not respond well to
standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug,
PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups.
Objectives:
- To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and
people with 17p deletion.
Eligibility:
- Individuals over 65 years of age who have CLL/SLL.
- Individuals at least 18 years of age who have CLL/SLL and 17p deletion.
Design:
- Participants will be screened with a medical history, physical exam, and imaging
studies. Blood and urine samples will be taken. Optional bone marrow and lymph node
biopsies may also be taken.
- Participants will take PCI-32765 capsules every day for 28 days (one cycle of
treatment). Treatment will be monitored with frequent blood tests and clinic visits.
- PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug
will continue to take it as long as there are no side effects and the disease does not
progress. Those who do not benefit will stop treatment and have regular followup exams.