Multicenter Study of Pacritinib Combined With Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Inclusion Criteria:

- Diagnosis of CLL/SLL

- Relapsed or refractory CLL or SLL following at least 1 prior line of systemic therapy
with active disease meeting criteria for treatment

- Age ≥18 and <80

- ECOG (Eastern Cooperative Oncology Group) ≤2 (This is a performance status that
attempts to quantify a patients daily activities where 0 represents normal activity
and 5 represents death)

- Adequate organ function defined as AST and ALT ≤ 2 times upper limit of normal (ULN),
Total Bilirubin ≤ 1.5 times ULN (exception of Gilbert disease), Renal function: CrCl
≥30 mL/min, Bazett-corrected Q-T interval ≤ 0.45 seconds

- Peripheral blood counts of ANC >500 cells/μL, platelets ≥ 50,000 cells/ μL,
Hemoglobin≥ 8 g/dL

- Prior treatment allowed if: at least 30 days have elapsed since last chemotherapy
and/or radiation and patient has recovered from all clinically significant
treatment-related toxicity, or at least 90 days have passed since date of autologous
stem cell transplant and patient has recovered to ≤grade 1 toxicity related to this
procedure.

- Ability to provide written informed consent

- Ability to take oral medications.

Exclusion Criteria:

- Pregnant or breast feeding women

- Primary or metastatic CNS (Central Nervous System) disease prior to study enrollment

- Uncontrolled current illness including, but not limited to, ongoing or active
infections requiring intravenous antimicrobials, symptomatic congestive heart failure,
unstable angina pectoris, unstable cardiac arrhythmia and/or psychiatric illness or
social situations that would limit compliance with study requirements

- Known HIV infection

- Active infection with Hepatitis B or C virus

- Concomitant therapy in last 30 days of any of the following: cytotoxic chemotherapy,
immunosuppressive agents, other investigational therapies or chronic use of systemic
corticosteroids

- Prior treatment with ibrutinib

- Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP).

- Requires anticoagulation with warfarin or equivalent Vit K antagonist

- Allergy to either ibrutinib or pacritinib or components within medication

- Treatment with strong CYP3A4 inducer or inhibitor, for which no alternative is
available.

- Unwilling or unable to use a medically acceptable form of contraception.

- Any gastrointestinal or metabolic condition that could interfere with the absorption
of oral medication.