Itacitinib + Everolimus for Hodgkin Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use strong or moderate CYP3A4 inhibitors or inducers and P-gp substrates. You also cannot use other anti-cancer agents or therapies during the study.
What data supports the effectiveness of the drug combination Itacitinib and Everolimus for treating Hodgkin Lymphoma?
Is the combination of Itacitinib and Everolimus safe for humans?
How is the drug Itacitinib + Everolimus unique for treating Hodgkin Lymphoma?
The combination of Itacitinib and Everolimus is unique because it targets specific pathways involved in cancer cell growth and survival, potentially offering a new approach for patients with relapsed or refractory Hodgkin Lymphoma who have not responded to other treatments. This combination leverages the effects of mTOR inhibitors like Everolimus, which have shown promise in other lymphoma treatments, and adds the novel action of Itacitinib, which may enhance the overall effectiveness.19101112
What is the purpose of this trial?
This is an open-label, single-group, Phase I/II study of itacitinib in combination with everolimus in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL).
Research Team
Jakub Svoboda, MD
Principal Investigator
University of Pennsylvania
Eligibility Criteria
Adults with relapsed classical Hodgkin lymphoma who've had at least two prior treatments and aren't eligible for high-dose therapy can join. They must have measurable disease, not be candidates for certain other therapies, and be free from other cancers for 2+ years. Good organ function is required, as well as agreement to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive combination treatment with itacitinib and everolimus to evaluate dose-limiting toxicities
Phase II Treatment
Participants continue treatment to evaluate the efficacy of itacitinib in combination with everolimus
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Everolimus
- Itacitinib
Everolimus is already approved in United States, European Union for the following indications:
- Advanced renal cell carcinoma
- Subependymal giant cell astrocytoma
- Progressive neuroendocrine tumors of pancreatic origin
- Advanced hormone receptor-positive, HER2-negative breast cancer
- Tuberous sclerosis complex-associated partial-onset seizures
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
- Prevention of organ rejection in kidney transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor