Actively Recruiting
A Pilot Study of Pacritinib Combined With a BTK Inhibitor in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Led by City of Hope Medical Center ยท Updated on 2026-04-07
10
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, side effects, and preliminary effectiveness of pacritinib combined with a Bruton's tyrosine kinase (BTK) inhibitor in patients with mantle cell lymphoma that has come back after improvement or did not respond to past treatments. This phase I trial aims to understand how this combination affects tumor growth and patient outcomes like response rate and progression-free survival. Participants receive pacritinib orally twice daily in 28-day cycles while continuing their prescribed BTK inhibitor treatment. Throughout the study, patients may undergo blood tests, optional tissue biopsies, bone marrow biopsies and aspirations, and PET/CT scans. Treatment continues until disease progression or unacceptable side effects occur, followed by a 30-day safety follow-up and ongoing monitoring every three months if no progression is observed. During the study, researchers monitor adverse events, overall response to treatment, duration of response, and progression-free survival up to 12 months. Additional evaluations explore tumor-associated macrophages, IL-10 expression, and minimal residual disease in patients with a complete metabolic response. Participants are closely assessed through laboratory tests, imaging, and clinical evaluations to understand the treatment's impact and safety over time.
CONDITIONS
Brief 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...
- Participants must provide documented informed consent
- Willingness to provide tissue from a fresh or diagnostic tumor biopsy prior to starting treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Histologically confirmed mantle cell lymphoma with specific immunophenotypic profile and relapsed or refractory disease after at least one prior systemic therapy
- Currently receiving a BTK inhibitor with prior response and evidence of progressive disease
- Radiographically measurable disease or confirmed bone marrow involvement
- Recovery from prior anti-cancer therapy toxic effects to grade 1 or less (except alopecia)
- Specific blood count thresholds depending on bone marrow involvement
- Liver and kidney function within defined limits
- Coagulation parameters within acceptable ranges
- Left ventricular ejection fraction of 50% or higher
- Corrected QT interval (QTc) of 480 ms or less
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during and after treatment as specified
You will not qualify if you...
- Autologous stem cell transplant within 3 months prior to treatment
- Prior allogeneic stem cell transplant
- Previous treatment with pacritinib or JAK2 inhibitors
- Concurrent treatment with pirtobrutinib
- Use of strong CYP3A4 inducers or inhibitors within 14 days prior to treatment
- Use of medications increasing bleeding risk or with arrhythmogenic potential within 14 days prior to treatment
- Systemic steroid therapy above specified doses except for allowed exceptions
- Significant recent bleeding or known bleeding disorders
- Conditions increasing risk of QT prolongation
- Clinically significant cardiovascular diseases within 3 months of screening
- Inability to swallow or retain oral medication
- Active gastrointestinal or metabolic conditions interfering with drug absorption
- Known hypersensitivity to study agents or related compounds
- Active central nervous system lymphoma involvement
- History of progressive multifocal leukoencephalopathy (PML)
- Other malignancies interfering with safety or efficacy assessments
- Active infections including hepatitis B, hepatitis C, or uncontrolled HIV
- Pregnant or breastfeeding women
- Any condition or circumstance that contraindicates participation or compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive pacritinib orally twice daily on days 1-28 of each 28-day cycle, continuing without disease progression or unacceptable toxicity. They also continue their BTK inhibitor as part of standard care. Blood samples, optional tissue biopsies, bone marrow biopsies and aspirations, and PET/CT scans are performed throughout the treatment.
Visits occur every 28 days during treatment cycles with additional assessments as needed
Duration - Up to 12 months or until disease progression
After completing study treatment, participants are followed up at 30 days for safety and then every 3 months if there is no disease progression.
1 visit at 30 days post-treatment and then quarterly visits
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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