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Tyrosine Kinase Inhibitor

Pacritinib for T-Cell Lymphoma

Phase 2
Recruiting
Led By Ryan Wilcox, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to take oral medication without crushing, dissolving or chewing tablets
Relapsed or refractory disease. Refractory disease is defined as progression during treatment or recurrent/progressive disease within 6 months of completing a treatment regimen that achieved either stable disease or a PR/CR. Relapsed disease is defined as progression or recurrence at least 6 months after a prior documented response (PR or CR)
Must not have
Any gastrointestinal or metabolic condition that could interfere with the absorption of oral medication
Prior allogeneic stem cell transplant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether pacritinib can help people with lymphoproliferative disorders who have relapsed or are refractory to other treatments.

Who is the study for?
This trial is for adults with certain types of T-cell lymphoma that have not responded to previous treatments or have come back after treatment. Participants must be able to take pills, understand and comply with study procedures, and use effective contraception if necessary. They should not have severe psychiatric issues, gastrointestinal conditions affecting drug absorption, uncontrolled illnesses like heart disease or infections, nor should they be pregnant.
What is being tested?
The trial is testing the effectiveness of a medication called Pacritinib in patients who have relapsed (cancer has returned) or refractory (not responding to treatment) T-cell lymphoproliferative disorders. The focus is on how well this oral drug works against these specific types of cancer.
What are the potential side effects?
While the side effects specific to Pacritinib are not listed here, common side effects for drugs treating similar conditions include nausea, fatigue, diarrhea, liver problems, increased risk of infection due to low blood cell counts and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills without needing to break them down.
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My disease came back or didn't respond to treatment within 6 months.
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I can take care of myself but might not be able to do heavy physical work.
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My diagnosis is a type of cutaneous T-cell lymphoma or peripheral T-cell lymphoma, as classified by WHO.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have stomach or metabolic issues affecting medicine absorption.
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I have had a stem cell transplant from a donor.
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I am HIV positive.
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I am not taking strong medication that affects liver enzymes.
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I haven't had a heart attack, stroke, or brain bleed in the last 6 months.
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My liver function is significantly impaired.
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I am taking more than 10 mg/day of steroids.
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I have been treated with pacritinib before.
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I have heart failure symptoms or my heart pumps less blood than normal.
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I have not fully recovered from my last cancer treatment or it was less than 14 days ago.
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I haven't had serious bleeding issues in the last 6 months.
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I do not have an irregular heartbeat that changes often.
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I have been diagnosed with Hepatitis B or C.
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I am currently on IV antibiotics for an infection.
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I need blood thinners like heparin or warfarin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Complete response rate (CRR)
Duration of response (DOR)
Progression- free survival (PFS).
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 40 Patients • NCT02891603
70%
Diarrhea
50%
Febrile neutropenia
50%
Dehydration
50%
Anorexia
40%
Mucositis oral
30%
Rash maculo-papular
30%
Nausea
30%
Fatigue
30%
Hypertension
20%
Colitis
20%
Neutrophil count decreased
20%
Alanine aminotransferase increased
20%
Platelet count decreased
20%
Abdominal pain
20%
Skin infection
20%
C Diff
20%
Pain in extremity
10%
Sinusitis
10%
Soft tissue infection
10%
Oral pain
10%
Creatinine increased
10%
Oral fungus
10%
Anemia
10%
Pain of skin
10%
Edema trunk
10%
Rectal pain
10%
Ileus
10%
Vomiting
10%
Aspartate aminotransferase increased
10%
Hyponatremia
10%
CMV+
10%
Electrocardiogram QT corrected interval prolonged
10%
Periorbital edema
10%
Anaphylaxis
10%
Headache -migraine
10%
Abdominal Pain
10%
Metabolism and nutrition disorders - Other
10%
Acute GVHD of skin
10%
Urticaria
10%
Metabolism and Nutrition disorders - Other
10%
Edema limbs
10%
Hypotension
10%
Thromboembolic event
10%
Hypoxia
10%
Insomnia
10%
Anxiety
10%
Hallucinations
10%
Headache
10%
Cardiac disorders - Other
10%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
Phase 2: Pacritinib With Sirolimus and Tacrolimus

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Less common PTCL subtypesExperimental Treatment1 Intervention
Patients will receive single agent pacritinib.
Group II: Cohort 3: CTCL (MF/SS)Experimental Treatment1 Intervention
Patients will receive single agent pacritinib.
Group III: Cohort 2: AITL/TFH PTCLExperimental Treatment1 Intervention
Patients will receive single agent pacritinib.
Group IV: Cohort 1: PTCL, NOSExperimental Treatment1 Intervention
Patients will receive single agent pacritinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pacritinib
2017
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,265 Total Patients Enrolled
1 Trials studying Lymphoproliferative Disorders
4 Patients Enrolled for Lymphoproliferative Disorders
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,659 Total Patients Enrolled
2 Trials studying Lymphoproliferative Disorders
5,136 Patients Enrolled for Lymphoproliferative Disorders
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,929 Total Patients Enrolled
86 Trials studying Lymphoproliferative Disorders
67,914 Patients Enrolled for Lymphoproliferative Disorders
~64 spots leftby Nov 2027
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