The main purpose of this study is to determine the effectiveness of the study drug pacritinib
in people with relapsed or refractory lymphoproliferative disorders.
Patients will receive single-agent treatment with pacritinib 200mg orally twice daily until
any condition for treatment discontinuation has been met. Patients will be enrolled into one
of four cohorts: Peripheral T-Cell Lymphoma, not otherwise specified (PTCL, NOS) (cohort 1);
angioimmunoblastic T-cell lymphoma/follicular helper T-cell (AITL/TFH) PTCL (cohort 2);
Cutaneous T-Cell Lymphoma (CTCL) - mycosis fungoides (MF) and Sezary syndrome (SS) (cohort
3); and other eligible, less common PTCL subtypes (cohort 4).
Selected Inclusion Criteria:
1. Ability to give informed consent.
2. ECOG performance status ≤ 2
3. A histologically confirmed diagnosis, per the WHO 2016 classification, of any PTCL or
CTCL subtype listed in the protocol.
4. Relapsed or refractory disease. Refractory disease is defined as progression during
treatment or recurrent/progressive disease within 6 months of completing a treatment
regimen that achieved either stable disease or a PR/CR. Relapsed disease is defined as
progression or recurrence at least 6 months after a prior documented response (PR or
5. Adequate organ and hematopoietic function as defined in the protocol.
6. Ability to take oral medication without crushing, dissolving or chewing tablets.
7. 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, comply with all requirements, and has an anticipated life expectancy of at
least 3 months.
Selected Exclusion Criteria:
1. 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
2. Pregnant or breast feeding women
3. 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.
4. Uncontrolled current illness, including, but not limited to the following:
1. Ongoing or active infections requiring intravenous antimicrobials
2. Symptomatic congestive heart failure (CHF) defined as NYHA class II, III or IV
(Appendix II), or ejection fraction <45% in any patient.
3. Unstable angina pectoris within 6 months of study enrollment
4. Unstable cardiac arrhythmia
5. History of myocardial infarction, stroke or intracranial hemorrhage within 6
months prior to enrollment
6. Moderate to severe hepatic impairment (Child-Pugh class B or C).
7. Psychiatric illness or social situations that would limit compliance with study
5. Known HIV infection
6. Known Hepatitis B or Hepatitis C infection
7. Recent (within 21 days of initiation of therapy, day 1) major surgery
8. Less than 14 days have elapsed since last radiation therapy or chemotherapy treatment
or patient has not recovered from all clinically significant treatmentrelated
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.
9. Use of systemic steroids at a dose equivalent to >10 mg/day of prednisone
10. Prior treatment with pacritinib
11. Requires anticoagulation with heparin, warfarin or equivalent Vit K antagonist
12. History of significant bleeding (≥ Grade 2 by CTCAE), bleeding diatheses, or bleeding
complications within the past 6 months.
13. Treatment with potent CYP450 inducers and strong CYP3A4 inhibitors (See Appendix IV),
for which no alternative is available. Treatment with strong CYP450 inducers or strong
CYP3A4 inhibitors within 2 weeks of initiation of therapy, day 1.
14. Concurrent administration of QTc prolonging agents. Significant QTc prolonging agents
must be stopped within 5 half-lives of day 1.
15. Any gastrointestinal or metabolic condition that could interfere with the absorption
of oral medication.
16. Prior allogeneic stem cell transplant.