NCT03697408

Itacitinib + Everolimus in Hodgkin Lymphoma

An Open-Label Phase I/II Safety and Efficacy Study of Itacitinib In Combination With Everolimus In Subjects With Relapsed/Refractory Classical Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is an open-label, single-group, Phase I/II study of itacitinib in combination with everolimus in subjects with relapsed or refractory cHL. Phase I will evaluate the safety and tolerability of itacitinib when combined with everolimus in subjects with relapsed refractory cHL using a 3 + 3 design; Phase II will evaluate the efficacy of the combination in subjects with cHL at the dose determined in Phase I using a Simon 2-stage expansion design. Subjects may continue to receive study treatment for 2 years or until evidence of disease progression, unacceptable toxicity, inability to obtain commercial everolimus or consent withdrawal.

Conditions

• Classical Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Itacitinib	A JAK 1 selective small molecule inhibitor
DRUG	Everolimus	A mammalian target of rapamycin (mTOR) inhibitor

Timeline

• Start date: 2019-02-11
• Primary completion: 2024-05-20
• Completion: 2027-06-01
• First posted: 2018-10-05
• Last updated: 2025-05-30
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study