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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can swallow pills without needing to break them down.
Select...
My disease came back or didn't respond to treatment within 6 months.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My diagnosis is a type of cutaneous T-cell lymphoma or peripheral T-cell lymphoma, as classified by WHO.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Complete response rate (CRR)
Duration of response (DOR)
Progression- free survival (PFS).
+2 moreSide effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0289160345%
Febrile neutropenia
41%
Mucositis oral
36%
Platelet count decreased
23%
Diarrhea
23%
Neutrophil count decreased
23%
Rash maculo-papular
18%
Anemia
18%
Hypertension
18%
Fatigue
14%
Headache
14%
Acute kidney injury
14%
Dehydration
9%
Anorexia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Hypotension
9%
Cellulitis
5%
Fever
5%
Multi-organ failure
5%
Lung infection
5%
C Diff
5%
Infusion related reaction
5%
Tremors
5%
Erythroderma -acute GVHD
5%
Folicular rash
5%
Rash over body
5%
Delirium
5%
Encephalitis - HHV6
5%
Encephalopathy
5%
Lung infection -Pneumonia
5%
Sepsis
5%
Mulit-organ failure
5%
Suspected VOD
5%
Abdominal distension
5%
Respiratory Failure
5%
Urinary tract pain
5%
Nausea
5%
Myocardial infarction
5%
Fall
5%
CPK increased
5%
Skin sloughing off
5%
Chills
5%
Tachycardia
5%
Fracture
5%
Electrocardiogram QT corrected interval prolonged
5%
Catheter related infection
5%
Bilirubin increase
5%
Dry mouth
5%
Creatinine increased
5%
White blood cell count decreased
5%
Abdominal Pain
5%
Sinusitis
5%
LDH Increased
5%
Alanine aminotransferase increased - VOD
5%
Alanine aminotransferase increased - suspected VOD
5%
Hypokalemia
5%
Erythroderma
5%
Diffuse rash on face, trunk, and extremities; eyelids swelling
5%
Pulmonary edema
5%
Dyspnea
5%
Hyponatremia
5%
Hypophosphatemia
5%
Meningitis
5%
Respiratory failure
5%
Insomnia
5%
Epistaxis
5%
Lethargy
5%
Gastrointestinal Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 1: Pacritinib With Sirolimus and Tacrolimus
Phase 1, Level 2: Pacritinib With Sirolimus and Tacrolimus
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
294 Previous Clinical Trials
24,021 Total Patients Enrolled
1 Trials studying Lymphoproliferative Disorders
4 Patients Enrolled for Lymphoproliferative Disorders
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,776 Total Patients Enrolled
2 Trials studying Lymphoproliferative Disorders
5,136 Patients Enrolled for Lymphoproliferative Disorders
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,754 Total Patients Enrolled
85 Trials studying Lymphoproliferative Disorders
67,882 Patients Enrolled for Lymphoproliferative Disorders
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in the current clinical experiment?
"This research initiative concluded its recruitment period. It first appeared on the 12th of December 2022 and was last updated in October 6th, 2022. For individuals with lymphoproliferative disorders, 2416 studies are open to potential participants while those looking for Pacritinib trials can choose from six different sites that are still accepting patients."
Answered by AI
Is this research project currently open to recruitment?
"As evidenced on clinicaltrials.gov, this study has ceased recruiting as of October 6th 2022. Initially posted on December 1st 2021, the trial is now closed for new participants; however there are 2,422 other investigations in which individuals can take part."
Answered by AI
Is this research a pioneering effort?
"Pacritinib has been in development since 2017, when the initial clinical trial conducted by CTI BioPharma was completed. After this 43-person Phase 1 & 2 study, Pacritinib received drug approval and several live trials have now sprouted up across 48 cities and 22 countries."
Answered by AI
Has the Federal Drug Administration approved Pacritinib for commercial distribution?
"Pacritinib's safety has been supported by some clinical data, so it was assigned a score of 2 on the risk scale. Unfortunately, no studies have yet proven its efficacy."
Answered by AI
Have any other investigations into the efficacy of Pacritinib been conducted?
"At present, 6 medical experiments are looking into the effectiveness of Pacritinib. One is currently in its third phase. The majority of these studies take place at 172 different sites with a concentration around Tampa, Florida."
Answered by AI
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