PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT01500733) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
United States86 participantsStarted 2012-01-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Cohort 1: Treated and untreated patients age 65 or older and need for therapy
✓. Men and women with histologically confirmed disease as defined by the following:
✓. Active disease as defined by at least one of the following:
✓. 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)
Exclusion criteria
What they're measuring
1
Overall Response Rate at 6 Months
Timeframe: 6 months
Trial details
NCT IDNCT01500733
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
. Previous radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product fpr CCL treatement in the last 4 weeks (i.e. intravenous immunoglobulin).
✕. Transformed CLL
✕. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy
✕. Impaired hepatic function: Total bilirubin greater than or equal to 1.5 times upper limit of normal unless dute to Gilbert's disease, AST/ ALT greater than or equal to 2.5 times institutional upper limit of normal unless due to infiltration of the liver.
✕. Impaired renal funtion: Creatinine greater than or equal to 2.0 mg/dL or GFR less than or equal to 50ml/min
✕. Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
✕. Concomitant immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \> 20 mg/day), or experimental therapy