Actively Recruiting
Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2026-04-07
10
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent
- Willing to provide tissue from fresh or prior tumor biopsy before starting treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Diagnosed with mantle cell lymphoma confirmed by WHO classification and immunophenotyping
- Relapsed or refractory disease after at least one prior systemic therapy
- Previously treated with a BTK inhibitor and showing disease progression
- Measurable disease by Lugano criteria or confirmed bone marrow/circulating disease
- Fully recovered from prior anti-cancer therapy side effects except alopecia
- Adequate neutrophil and platelet counts based on bone marrow involvement
- Liver enzymes and bilirubin within specified limits
- Kidney function with creatinine clearance of 30 mL/min or higher
- Blood clotting tests within normal or therapeutic ranges
- Heart function with left ventricular ejection fraction 50% or higher
- Corrected QT interval (QTc) of 480 ms or less
- Negative pregnancy test for women of childbearing potential
- Agree to abstain or use highly effective birth control during treatment and for a specified period after
You will not qualify if you...
- Autologous stem cell transplant within 3 months before treatment
- Prior allogeneic stem cell transplant
- Previous treatment with pacritinib or JAK2 inhibitors
- Concurrent treatment with pirtobrutinib
- Recent use of strong CYP3A4 inducers or inhibitors
- Use of medications increasing bleeding risk or with arrhythmogenic potential recently
- Systemic steroid therapy not tapered to 20 mg/day prednisone or equivalent with exceptions
- Significant recent bleeding history or known bleeding disorders
- Risk factors for QT interval prolongation
- Serious cardiovascular disease or recent heart events
- Inability to swallow or retain oral medication
- Active gastrointestinal or metabolic conditions affecting drug absorption
- Active or uncontrolled bowel disorders
- Known allergies to study drugs or related compounds
- Central nervous system involvement by lymphoma or history of progressive multifocal leukoencephalopathy
- Prior or concurrent malignancies interfering with study
- Active infections including certain viral infections or major infections recently
- Pregnant or breastfeeding women
- Any condition or factor that may prevent study participation or compliance as judged by the investigator
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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