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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06675123
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Dec 2025
Primary completion
Mar 8, 2028
Completion
Mar 8, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pacritinib, BTK inhibitor)
    Patients receive pacritinib PO 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 PET/CT throughout the study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 30 days after last dose of study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Tycel J. Phillips
[email protected]
626-256-4673
Tycel J. Phillips (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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