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BTK Inhibitor
Pacritinib + BTK Inhibitor for Mantle Cell Lymphoma
Phase 1
Waitlist Available
Led By Tycel J Phillips
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Specific renal function test within normal limits
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Must not have
Prior allogeneic stem cell transplant
Active HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and effectiveness of using pacritinib along with a BTK inhibitor to treat patients with mantle cell lymphoma that has come back or has not responded to previous treatment.
Who is the study for?
This trial is for patients with Mantle Cell Lymphoma that has either returned after treatment or hasn't responded to previous treatments. Participants should be suitable for biopsies and imaging tests like PET and CT scans.
What is being tested?
The trial is testing the safety and effectiveness of pacritinib combined with a BTK inhibitor, both aimed at stopping tumor growth by targeting specific enzymes and proteins in white blood cells.
What are the potential side effects?
Potential side effects may include fatigue, nausea, bruising or bleeding due to low platelet counts, diarrhea, muscle pains, rash, dizziness, shortness of breath, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function tests are normal.
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I am able to get out of my bed or chair and move around.
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I am not pregnant.
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I am willing to provide a tissue sample from my tumor for testing.
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I am 18 years old or older.
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My diagnosis is mantle cell lymphoma, confirmed by a biopsy.
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My condition worsened or didn't improve after at least one treatment.
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I am currently being treated with a BTK inhibitor.
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I have recovered from the side effects of my previous cancer treatment.
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My heart functions within normal limits.
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My liver function tests are normal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stem cell transplant from a donor.
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I have an active HIV infection.
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I cannot swallow pills.
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My lymphoma has spread to my brain or spinal cord.
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I have previously been treated with pacritinib or a JAK2 inhibitor.
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I am currently being treated with pirtobrutinib.
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I have a history of significant bleeding or a known bleeding disorder.
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I have a serious heart condition.
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I have a stomach or metabolic issue affecting how my body absorbs medicine.
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I have had progressive multifocal leukoencephalopathy in the past.
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I do not have another cancer that could affect the trial's safety or results.
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I have an active hepatitis B or C infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events (AEs)
Secondary study objectives
Duration of response (DOR)
Overall response rate (ORR)
Progression-free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pacritinib, BTK inhibitor)Experimental Treatment8 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Biopsy
2014
Completed Phase 4
~1090
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Pacritinib
2017
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,570 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,019 Total Patients Enrolled
Tycel J PhillipsPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
50 Total Patients Enrolled
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