City of Hope Medical Center
This phase I trial tests the safety and side effects of pacritinib in combination with a Bruton's tyrosine kinase (BTK) inhibitor and how well it works in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. BTK inhibitors block a protein called BTK which is present on B-cell (a type of white blood cell) cancers such as mantle cell lymphoma at abnormal levels. This may help keep tumor cells from growing and spreading. Giving pacritinib in combination with a BTK inhibitor may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
PRIMARY OBJECTIVE: I. Obtain a preliminary estimate of the safety and tolerability of the combination of pacritinib with a covalent BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib) in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. Obtain a preliminary estimate of the overall response rate (ORR) of the combination of pacritinib with a BTK inhibitor in patients with R/R MCL. II. Obtain a preliminary estimate of the duration of response and progression-free survival in patients with R/R MCL treated with a combination of pacritinib with…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification with a characteri…
Undergo optional tissue biopsy
Undergo blood sample collection
Undergo bone marrow biopsy and aspiration
Undergo bone marrow biopsy and aspiration
Given BTK inhibitor
Undergo PET/CT
Given PO
Undergo PET/CT
Arctuva estimate
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