NCT06675123

Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

A Pilot Study of Pacritinib Combined With a BTK Inhibitor in Patients With Relapsed/Refractory Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 a BTK inhibitor. EXPLORATORY OBJECTIVES: I. Explore the association between clinical outcomes, elimination of tumor associated macrophages (TAMs), and expression of IL-10. II. Evaluate minimal residual disease (MRD) in patients who obtain a complete metabolic response to therapy. OUTLINE: Patients receive pacritinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also continue to receive BTK inhibitor per standard of care. Additionally, patients undergo blood sample collection, optional tissue biopsy, bone marrow biopsy and aspiration and positron emission tomography (PET)/computed tomography (CT) throughout the study. After completion of study treatment, patients are followed up at 30 days. Patients without progression are followed up every 3 months.

Conditions

• Recurrent Mantle Cell Lymphoma
• Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo optional tissue biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow biopsy and aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy and aspiration
DRUG	BTK Inhibitor	Given BTK inhibitor
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Pacritinib	Given PO
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-03-08
• Completion: 2028-03-08
• First posted: 2024-11-05
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study