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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT03697408•University of Pennsylvania

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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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to understand and voluntarily sign the informed consent form.
•2. Aged 18 years or older at the time of signing the informed consent form.
•3. Biopsy-proven diagnosis of relapsed classical Hodgkin lymphoma.
•4. Measurable disease on imaging defined as at least one lesion that can be accurately measured in at least two dimensions by imaging (PET/CT, CT or MRI). Minimum measurement must be ≥ 15mm in the longest axis or ≥ 10mm in the short axis.
•5. Relapsed or refractory disease (after at least 2 prior systemic therapies); patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT based upon the below criteria:
•* Patients that have either progressed after treatment with, be intolerant to, or are not a candidate for brentuximab and pembrolizumab or nivolumab. The reason for forgoing such therapies must be clearly documented.
•* Are not ASCT candidates due to chemo-resistant disease (unable to achieve CR or PR to salvage chemotherapy), advanced age (≥ 65 years of age), or any significant coexisting medical condition (renal, pulmonary, or hepatic dysfunction) likely to have a negative impact on tolerability of ASCT
•6. Disease free of other malignancies for greater than or equal to 2 years with the exception of basal cell, squamous cell carcinomas of the skin, fully excised melanoma in situ, carcinoma in situ of the cervix or breast.
•7. Performance status of ECOG 0-2 (Appendix 13.3).
•8. Laboratory test results within these ranges (of note, patients who have cytopenias due to documented cHL involvement of the bone marrow may be considered for enrollment after discussion with the PI, Medical Director and Sponsor):
+10 more criteria

Exclusion Criteria

•1. Unable to sign informed consent form.
•2. Pregnant or breast-feeding females (lactating females must agree not to breast feed while taking the investigational agents).
•3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. For Example:
•* symptomatic congestive heart failure of New York Heart Association Class III or IV
•* unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
•* severely impaired lung function with O2 saturation that is 88% or less at rest on room air
•* active (acute or chronic) or uncontrolled severe infections
•* condition requiring ongoing use of medications that are considered STRONG or MODERATE CYP3A4 inhibitors or inducers and P-gp substrates at study screening . However, those who require weak inhibitors/inducers can be enroll at discretion of the PI.
•* liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
•4. Has a history (within the past 12 months) of (non-infectious) pneumonitis requiring systemic steroids, or active pneumonitis.
+5 more criteria

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

February 11, 2019

Primary Completion Date

May 20, 2024

Completion Date

June 1, 2027

Last Updated

May 30, 2025

Enrollment

ACTUAL participants

Conditions

Classical Hodgkin Lymphoma

Interventions

Itacitinib

DRUG

Everolimus

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Itacitinib + Everolimus in Hodgkin Lymphoma

Inclusion Criteria

Exclusion Criteria

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