This trial will determine the safety and tolerability of Pacritinib in patients with relapsed/refractory lymphoproliferative disorders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Patients will receive continuous treatment until progressive disease, toxicity, or until any other condition for treatment discontinuation has been met.
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Rate of dose limiting toxicities (DLT)
Dose limiting toxicity (DLT) rate during the 1st cycle (28 days) of pacritinib.
Time frame: At 28 days
The proportion of patients that respond to treatment
Overall response rate (ORR), defined as best disease response recorded from first day of treatment until disease progression or initiation of new antineoplastic therapy. Responses for patients with NHL or small lymphocytic lymphoma will be performed in accordance with the Revised Lugano classification staging system for non-Hodgkin's Lymphoma. Responses for patients with CLL will be evaluated in accordance with criteria of the International Workshop on Chronic Lymphocytic Leukemia, with the exception that lymphocytosis will not be the sole criteria for disease progression. Responses for CTCL will be assessed by the modified Severity Weighted Assessment Tool, response in blood, nodes, viscera, and the global composite scoring system.
Time frame: Up to 2 years
The proportion of patients that experience a complete response (CR)
Responses for patients with NHL or small lymphocytic lymphoma will be performed in accordance with the Revised Lugano classification staging system for non-Hodgkin's Lymphoma. Responses for patients with CLL will be evaluated in accordance with criteria of the International Workshop on Chronic Lymphocytic Leukemia, with the exception that lymphocytosis will not be the sole criteria for disease progression. Responses for CTCL will be assessed by the modified Severity Weighted Assessment Tool, response in blood, nodes, viscera, and the global composite scoring system.
Time frame: Up to 2 years
Duration of response (DOR)
DOR, defined as time from documented remission to the time of death, relapse, or initiation of alternative antineoplastic. Responses for patients with NHL or small lymphocytic lymphoma will be performed in accordance with the Revised Lugano classification staging system for non-Hodgkin's Lymphoma. Responses for patients with CLL will be evaluated in accordance with criteria of the International Workshop on Chronic Lymphocytic Leukemia, with the exception that lymphocytosis will not be the sole criteria for disease progression. Responses for CTCL will be assessed by the modified Severity Weighted Assessment Tool, response in blood, nodes, viscera, and the global composite scoring system.
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Time frame: Up to 2 years
Time to next treatment
Time to next treatment, defined as time from first dose of pacritinib to initiation of alternative antineoplastic therapy
Time frame: Up to 2 years