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.
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
Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy
Prior allogeneic stem cell transplant
Prior treatment with pacritinib or a janus kinase 2 (JAK2) inhibitor
Concomitant treatment with pirtobrutinib
Single group
Biopsy
Procedure/SurgeryUndergo optional tissue biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow biopsy and aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy and aspiration
BTK Inhibitor
DrugGiven BTK inhibitor
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Pacritinib
DrugGiven PO
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Incidence of adverse events (AEs)
Will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by type, severity, and attribution.
Overall response rate (ORR)
Will be defined as the proportion of response evaluable participants that achieve a best response of either complete metabolic response (CMR) or partial metabolic response (PMR) after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. ORR will be estimated along with the 95% exact binomial confidence interval.
Duration of response (DOR)
DOR will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when available. Descriptive analyses may be done separately for particular Bruton's tyrosine kinase (BTK) inhibitor(s) depending on the number of patients treated.
Progression-free survival (PFS)
PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error, 95% confidence interval will be constructed based on log-log transformation. Median PFS will be estimated when available. Descriptive analyses may be done separately for particular BTK inhibitor(s) depending on the number of patients treated.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
