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



Status:Withdrawn
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 79
Updated:9/7/2017
Start Date:October 2016
End Date:October 2018

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Phase I/II, Open Label, Multicenter Study of Pacritinib Combined With Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

This study combines two drugs in the treatment of relapsed/refractory chronic lymphocytic
leukemia (CLL) and small lymphocytic lymphoma (SLL). Investigators are proposing combining
ibrutinib, an orally-administered, small molecule inhibitor of Bruton's tyrosine kinase (FDA
approved for the treatment of relapsed/refractory CLL), with pacritinib, a novel JAK2-FLT3
inhibitor that has shown activity in relapsed lymphoma, including CLL/SLL. Investigators will
first demonstrate the safety and tolerability of Pacritinib when combined with Ibrutinib in a
phase I study, which will help establish the MTD (Maximum Tolerated Dose)of Pacritinib when
combined with Ibrutinib. Once the optimal dose of Pacritinib is established in the phase I
setting, a phase II evaluation will seek to establish the efficacy of the combination of
Pacritinib with Ibrutinib. Patients will receive continuous treatment until progressive
disease and will be followed while on study treatment for a total of 2 years.


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.
We found this trial at
2
sites
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Rochester, Minnesota 55905
Phone: 507-266-0792
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