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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up 12 months for reporting.

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

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Biopsy

2014

Completed Phase 4

~1150