PCI-32765 for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byAndy Itsara, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andy Itsara, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

This trial is for adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. It's specifically for those over 65, or at least 18 with a genetic abnormality called 17p deletion. Participants must be able to swallow capsules and agree to use contraception if they can have children.

Inclusion Criteria

Active disease as defined by weight loss greater than or equal to 10% within the previous 6 months, extreme fatigue, fevers of greater than 100.5 degrees F for greater than or equal to 2 weeks without evidence of infection, night sweats for more than one month without evidence of infection, evidence of progressive marrow failure, massive or progressive splenomegaly, massive nodes or clusters or progressive lymphadenopathy, progressive lymphocytosis, compensated autoimmune hemolysis, Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2, ANC greater than 500/microL, platelets greater than 30,000/microL, agreement to use contraception during the study and for 90 days after the last dose of study drug if sexually active and able to bear children, willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty, ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)

I am 65 or older and need treatment.

I am over 18 and have cancer with specific genetic changes.

See 1 more

Exclusion Criteria

Known hypersensitivity to any component of PCI-32765

I have never taken PCI 32765 or any BTK inhibitors.

I need to take warfarin for blood thinning.

See 14 more

Treatment Details

Interventions

PCI-32765 (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial OverviewThe trial tests PCI-32765, a new drug for treating CLL/SLL in older patients and those with the 17p deletion who often don't do well on standard treatments. Patients take daily capsules for six cycles and may continue if beneficial without severe side effects.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Elderly greater than 65Experimental Treatment1 Intervention

Group II: 17p DeletioinExperimental Treatment1 Intervention