About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Biopsy
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- BTK Inhibitor
- Computed Tomography
- Pacritinib
- Positron Emission Tomography
Treatment groups
Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator