- Diagnosis of any of the following: Relapsed/refractory cutaneous (stage IIb-IV) or
peripheral T-cell lymphoma with progression after at least one prior therapy
(including brentuximab vedotin for patients with anaplastic large cell lymphomas);
Chronic lymphocytic leukemia (CLL), splenic marginal zone lymphoma (SMZL),
Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) or mantle cell
lymphoma (MCL) with disease progression on ibrutinib or who discontinue ibrutinib due
to toxicity/intolerance; any lymphoproliferative disorder who have failed at least 2
prior therapies and have had mutational analysis or sequencing studies performed in a
CLIA certified laboratory demonstrating a mutation or gene fusion involving MyD88,
JAK2, JAK3, TYK2, or IRAK1 that are known or suspected to be "activating"
- Age ≥ 18 at time of enrollment
- ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general
well-being and activities of daily life; scores range from 0 to 5 where 0 represents
perfect health and 5 represents death.)
- Adequate organ and marrow function as defined in the protocol
- Ability to take oral medication without crushing, dissolving or chewing tablets.
- In the investigator's opinion, the patient requires immediate treatment.
- Ability to understand and the willingness to sign a written informed consent.
- In the investigator's opinion, the patient has the ability to communicate
satisfactorily with the investigator and the study team, to participate fully in the
study, and comply with all requirements.
- History of, or a concurrent, clinically significant illness, medical condition or
laboratory abnormality that, in the investigator's opinion, could affect the conduct
of the study
- Pregnant or breast feeding women
- Unwilling or unable to use a medically acceptable form of contraception during the
time of participation in the trial (sexual abstinence is permissible) unless
documented successful vasectomy, hysterectomy, bilateral oophorectomy or
post-menopausal for at least 2 years
- Uncontrolled current illness, including, but not limited to the following: Ongoing or
active infections requiring intravenous antimicrobials; symptomatic congestive heart
failure defined as NYHA class II, III or IV (Appendix II); unstable angina pectoris
within 6 months of study enrollment; unstable cardiac arrhythmia; history of
myocardial infarction, stroke or intracranial hemorrhage within 6 months prior to
enrollment; moderate to severe hepatic impairment (Child-Pugh class B or C);
psychiatric illness or social situations that would limit compliance with study
- Known HIV infection
- Known positive Hepatitis B surface antigen or Hep C virus
- Recent (within 21 days of initiation of therapy, day 1) major surgery
- Less than 14 days have elapsed since last radiation therapy or chemotherapy treatment
or patient has not recovered from all clinically significant treatment-related
toxicity; less than 90 days have passed since date of autologous stem cell transplant
and patient has not recovered to ≤grade 1 toxicity related to this procedure
- Use of systemic steroids (oral, inhaled, nasal, topical) at a dose less > 10 mg/day of
- Prior treatment with pacritinib
- Uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP).
Coombs positivity in absence of hemolysis is not an exclusion.
- Requires anticoagulation with heparin, warfarin or equivalent Vit K antagonist
- History of significant bleeding (≥Grade 2 by CTCAE) history or complications
(including bleeding that may have occurred while on ibrutinib)
- Hypersensitivity or allergic reaction to compounds related to pacritinib
- Treatment with potent CYP450 inducers and strong CYP3A4 inhibitors for which no
alternative is available; treatment with strong CYP450 inducers or strong CYP3A4
inhibitors within 2 weeks of initiation of therapy, day 1
- Concurrent administration of QTc prolonging agents; significant QTc prolonging agents
must be stopped within 5 half-lives of day 1.
- Any gastrointestinal or metabolic condition that could interfere with the absorption
of oral medication