100 Participants Needed

Pacritinib for T-Cell Lymphoma

Recruiting at 5 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.

Do I need to stop taking my current medications for the trial?

The trial requires a 2-week break from strong CYP3A4 inducers or inhibitors before starting the study drug. Also, medications that prolong QTc must be stopped within 5 half-lives before starting the trial. If you are on these medications, you may need to stop or adjust them.

What makes the drug Pacritinib unique for treating T-cell lymphoma?

Pacritinib is unique because it is a targeted therapy that inhibits specific enzymes involved in cancer cell growth, which may offer a novel approach compared to traditional chemotherapy regimens used for T-cell lymphoma. This could potentially provide an option for patients who do not respond well to existing treatments.12345

Who Is on the Research Team?

Ryan Alan Wilcox MD, PhD | Clinical ...

Ryan Wilcox, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can swallow pills without needing to break them down.
Ability to give informed consent
My disease came back or didn't respond to treatment within 6 months.
See 4 more

Exclusion Criteria

I don't have stomach or metabolic issues affecting medicine absorption.
I have not had major surgery in the last 3 weeks.
I have stopped taking medications that affect my heart's rhythm.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive single-agent treatment with pacritinib 200mg orally twice daily until any condition for treatment discontinuation has been met

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post end of treatment

Long-term follow-up

Participants are monitored for long-term outcomes such as progression-free survival and duration of response

Up to approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pacritinib
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Less common PTCL subtypesExperimental Treatment1 Intervention
Group II: Cohort 3: CTCL (MF/SS)Experimental Treatment1 Intervention
Group III: Cohort 2: AITL/TFH PTCLExperimental Treatment1 Intervention
Group IV: Cohort 1: PTCL, NOSExperimental Treatment1 Intervention

Pacritinib is already approved in United States for the following indications:

🇺🇸
Approved in United States as Vonjo for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 420 patients with peripheral T-cell lymphoma (PTCL), those with relapsed disease had a significantly higher objective response rate (61%) and complete response rate (41%) to second-line therapy compared to primary refractory patients, who had response rates of 40% and 14%, respectively.
Relapsed patients also experienced better overall survival, with a median of 29.1 months, compared to 12.3 months for refractory patients, highlighting the need for improved front-line therapies for PTCL.
Outcomes for Relapsed and Refractory Peripheral T-Cell Lymphoma Patients after Front-Line Therapy from the COMPLETE Registry.Lansigan, F., Horwitz, SM., Pinter-Brown, LC., et al.[2020]
In a study of 1344 patients with peripheral T-cell lymphoma (PTCL), those treated with brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A + CHP) had a lower rate of subsequent therapy compared to those treated with CHOP, indicating potentially better initial treatment efficacy.
The study highlighted that patients in the real-world setting were older and had more comorbidities than those in clinical trials, emphasizing the need for retrospective analyses to understand the impact of new treatments in diverse patient populations.
Retrospective Analysis With Propensity Score Matching of Peripheral T-Cell Lymphoma Treated Frontline With Brentuximab Vedotin and Chemotherapy.Burke, JM., Liu, N., Yu, KS., et al.[2023]
Alisertib (MLN8237), an oral Aurora A kinase inhibitor, has demonstrated the ability to reduce cell proliferation and induce apoptosis in various tumor cell lines, making it a promising treatment for aggressive peripheral T-cell lymphomas.
Currently undergoing Phase III trials, alisertib has shown single-agent antitumor activity in animal models and potential effectiveness in patients with relapsed or refractory peripheral T-cell lymphoma, highlighting its importance in developing new therapies for this challenging condition.
The role of alisertib in treatment of peripheral T-cell lymphomas.Gallop-Evans, E.[2015]

Citations

Outcomes for Relapsed and Refractory Peripheral T-Cell Lymphoma Patients after Front-Line Therapy from the COMPLETE Registry. [2020]
Retrospective Analysis With Propensity Score Matching of Peripheral T-Cell Lymphoma Treated Frontline With Brentuximab Vedotin and Chemotherapy. [2023]
The role of alisertib in treatment of peripheral T-cell lymphomas. [2015]
Treatment of Peripheral T-Cell Lymphoma: Many Shades of Gray. [2015]
Antitumor activity and safety of camrelizumab combined with apatinib in patients with relapsed or refractory peripheral T-cell lymphoma: An open-label, multicenter, phase II study. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security