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Protocol Details

A Phase II study of Ibrutinib for Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Need Therapy and are Older than 65 or have a 17p Deletion

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Malignancy of B Cells;
Hematopoietic Neoplasms;
Bruton's Tyrosine Kinase

Recruitment Keyword(s)



Patients with a 17p Deletion;
B-cell receptor (BCR);
Bruton's Tyrosine Kinase;
Malignancy of B Cells;
Hematopoietic Neoplasms

Investigational Drug(s)


Investigational Device(s)



Drug: PCI 32765

Supporting Site

National Heart, Lung and Blood Institute


- Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood cancer 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, ibrutinib, to see if it can treat CLL/SLL in these hard-to-treat groups.


- To see if ibrutinib is a safe and effective treatment for CLL/SLL in older people and people with 17p deletion.


- Individuals over 65 years of age who have CLL/SLL.

- Individuals at least 18 years of age who have CLL/SLL and 17p deletion.


- 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 ibrutinib capsules every day for 28 days (one cycle of treatment). Treatment will be monitored with frequent blood tests and clinic visits.

- Ibrutinib 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 follow up exams.

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1. Cohort 1: Treated and untreated patients age 65 or older and need for therapy

Cohort 2: Treated (maximum accrual n=16) and untreated (n=27, evaluable) patients at least 18 years old with 17p deletion or p53 expression by immunohistochemistry or p53 mutation by sequencing analysis.

2. Men and women with histologically confirmed disease as defined by the following:

-B-lymphocytosis greater than 5000 cells/microL (may be less than 5000 cells/microL if lymphadenopathy is present with histologic confirmation of lymph node involvement by SLL)

-Immunophenotypic profile read by an expert pathologist as consistent with CLL. This will include CD5, CD19, and CD20 expression by the CLL cells typically also with CD23 expression, but CD23 negative cases may be included if there is no t11;14 translocation present.

3. Active disease as defined by at least one of the following:

-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 as manifested by the development of, or worsening of, anemia and/or thrombocytopenia

-Massive or progressive splenomegaly

-Massive nodes or clusters or progressive lymphadenopathy

-Progressive lymphocytosis with an increase of greater than 50% over a 2 month period, or an anticipated doubling time of less than 6 months

-Compensated autoimmune hemolysis

4. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2

5. ANC greater than 500/microL, platelets greater than 30,000/microL

6. 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

7. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty

8. 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)


1. Previous radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product fpr CCL treatement in the last 4 weeks (i.e. intravenous immunoglobulin).

2. Transformed CLL

3. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy

4. 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.

5. Impaired renal funtion: Creatinine greater than or equal to 2.0 mg/dL or GFR less than or equal to 50ml/min

6. 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 ibrutinib PO, or put the study outcomes at undue risk

7. Concomitant immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone > 20 mg/day), or experimental therapy

8. Active Hepatitis B infection

9. HIV infection

10. Female patients: Current pregnancy or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential or currently breastfeeding. Male patients who are unwilling to follow the contraception requirements described in this protocol.

11. Psychiatric illness/social situations that would limit the patient s ability to tolerate and/or comply with study requirements.

12. Unable to understand the investigational nature of the study or give informed consent.

13. Individuals < 18 yrs old

14. Known hypersensitivity to any component of ibrutinib

15. Any prior therapy with ibrutinib or any other BTK inhibitors.

16. Requires anticoagulation with warfarin.

17. Requires treatment with strong CYP3A and/or CYP2D6 inhibitors (unless no alternative is available)

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Adrian U. Wiestner, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 3-5140
(301) 594-6855

Susan Soto, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4-5362
10 Center Drive
Bethesda, Maryland 20892
(301) 402-0797

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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