Pacritinib for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests pacritinib, a drug that may benefit individuals with certain types of T-cell lymphoma, a cancer affecting the immune system. The main goal is to evaluate pacritinib's effectiveness for those whose cancer has returned or is not responding to previous treatments. Suitable participants have a confirmed diagnosis of a T-cell lymphoma type that is either relapsed (returned) or refractory (resistant to treatment) and are experiencing progression despite prior treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that pacritinib is likely to be safe for humans?
Research has shown that pacritinib is generally well-tolerated in people with certain recurring or hard-to-treat blood disorders. In earlier studies, common side effects included diarrhea, low platelet count (thrombocytopenia), nausea, low red blood cell count (anemia), and swelling from fluid retention (peripheral edema), occurring in 20% or more of patients.
The FDA has approved pacritinib for treating myelofibrosis, a different condition, which suggests it is somewhat safe. However, reports have noted lymphoma and other cancers, particularly in individuals who smoke or have smoked. Most patients managed these side effects with proper care.
Overall, while pacritinib has shown some side effects, its use in other conditions suggests it is relatively safe when monitored by a doctor.12345Why do researchers think this study treatment might be promising for lymphoma?
Pacritinib is unique because it specifically targets the JAK2 and FLT3 pathways, which are often involved in the growth of T-cell lymphomas. Unlike traditional chemotherapy that broadly attacks fast-growing cells and might affect healthy cells, Pacritinib offers a more targeted approach, potentially reducing side effects. Researchers are excited about this treatment because it could provide a new option for patients with challenging subtypes of T-cell lymphoma, like PTCL, NOS, and AITL, that don't always respond well to existing therapies. Additionally, its oral administration offers a convenient alternative to intravenous treatments, making it easier for patients to adhere to their treatment regimen.
What evidence suggests that pacritinib might be an effective treatment for T-cell lymphoma?
Research has shown that pacritinib may help treat certain blood disorders. In earlier studies, over 80% of patients experienced symptom relief compared to those on other treatments. Pacritinib blocks signals in cancer cells that aid their survival and growth, making it potentially useful for conditions like T-cell lymphoma, where cancer cells depend on these signals. In this trial, participants will receive pacritinib as a single agent across different cohorts, each focusing on specific subtypes of T-cell lymphoma. Long-term treatment data suggest that most patients tolerate the treatment well. These findings support the idea that pacritinib could be a helpful option for those with relapsed or hard-to-treat blood disorders.14678
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive single-agent treatment with pacritinib 200mg orally twice daily until any condition for treatment discontinuation has been met
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes such as progression-free survival and duration of response
What Are the Treatments Tested in This Trial?
Interventions
- Pacritinib
Pacritinib is already approved in United States for the following indications:
- Intermediate or high-risk primary or secondary myelofibrosis with platelet counts below 50 × 10^9/L
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Hoosier Cancer Research Network
Collaborator
CTI BioPharma
Industry Sponsor
Dr. Adam R. Craig
CTI BioPharma
Chief Executive Officer since 2017
Member of the Royal College of Physicians (UK)
Dr. Monica Ravindra Shah
CTI BioPharma
Chief Medical Officer
MD from Brown Medical School
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator