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Classical Hodgkin LymphomaPhase 1/2NCT03697408

Itacitinib + Everolimus in Hodgkin Lymphoma

A Phase 1/2 study testing Itacitinib and Everolimus in people with Classical Hodgkin Lymphoma, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Classical Hodgkin Lymphoma
What is being tested?
Itacitinib and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
11 Feb 2019to Jun 2027
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to understand and voluntarily sign the informed consent form.
  • Aged 18 years or older at the time of signing the informed consent form.
  • Biopsy-proven diagnosis of relapsed classical Hodgkin lymphoma.
  • 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.
  • 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.
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  • 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
  • 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.
  • Performance status of ECOG 0-2 (Appendix 13.3).
  • 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):
  • Absolute neutrophil count (ANC) > 1,000/µL
  • Platelet count > 75,000/µL
  • Serum creatinine < 2.0 mg/dL
  • Bilirubin < 2.0 × ULN unless bilirubin increase was due to Gilbert's disease. Further evaluation should be performed to confirm and document the origin of increase.
  • AST and ALT ≤ 2.5 × institutional upper limit of normal (ULN)
  • Fasting cholesterol ≤ 300 mg/dL AND fasting triglycerides ≤ 300 mg/dl. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication prior initiating study treatment.
  • Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 72 hours prior to the first dose of itacitinib and must agree to use an effective contraception method during the study and for 6 months following the last dose of study drug; females of non-childbearing potential are those who are post-menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy. Female patients undergoing active fertility preservation therapy/egg harvesting which include hCG injections are expected to have mild elevation of hCG. These patients may be allowed to participate in the trial despite elevation of hCG after providing documentation of negative hCG prior the hCG injection and statement from her fertility specialist that they are not pregnant.
  • Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug.
  • Must be able to comply with the study and follow-up requirements.
  • Subject must have access to everolimus via insurance or self-pay.

Who cannot join

  • Unable to sign informed consent form.
  • Pregnant or breast-feeding females (lactating females must agree not to breast feed while taking the investigational agents).
  • 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
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  • 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).
  • Has a history (within the past 12 months) of (non-infectious) pneumonitis requiring systemic steroids, or active pneumonitis.
  • Bilirubin < 3 × ULN in the presence of liver metastases or presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia)
  • Concurrent use of other anti-cancer agents or therapies during study treatment.
  • Use of any other experimental drug or therapy within 28 days of initiating treatment with the investigational agents.
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis C (HCV), or hepatitis B virus (HBV); patients who are seropositive because of hepatitis B virus vaccine are eligible.
  • Previous use of JAK1 inhibitor (itacitinib), or history of progression on everolimus.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Itacitinib, Everolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItacitinibDrug

    Also called INCB039110

    A JAK 1 selective small molecule inhibitor

  • EverolimusDrug

    Also called Afinitor

    A mammalian target of rapamycin (mTOR) inhibitor

Study groups in NCT03697408
Study groupRoleWhat they receive
Cohort -1ExperimentalItacitinib 200 mg once daily (QD) in combination with everolimus 5 mg QD
Receives: Drug: Itacitinib; Drug: Everolimus
Cohort 1 (starting dose)ExperimentalItacitinib 300 mg once daily (QD) in combination with everolimus 5 mg QD
Receives: Drug: Itacitinib; Drug: Everolimus
Cohort 2ExperimentalItacitinib 400 mg once daily (QD) in combination with everolimus 5 mg QD
Receives: Drug: Itacitinib; Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase II: Efficacy of Itacitinib in Combination With Everolimus

    Evaluate the efficacy of itacitinib in combination with everolimus in subjects with relapsed or refractory cHL as demonstrated by complete response (CR) rate, defined as the percentage of subjects achieving CR as their best response.

    Measured: 2 Years

Secondary outcomes (6)

  1. Determine the Efficacy of Itacitinib in Combination With Everolimus in Terms of Overall Response Rate (ORR).

    Measured: 2 years

  2. Determine the Efficacy of Itacitinib in Combination With Everolimus in Terms of Partial Response (PR).

    Measured: 2 years

  3. Determine the Efficacy of Itacitinib in Combination With Everolimus in Terms of Stable Disease (SD).

    Measured: 2 years

  4. Determine the Efficacy of Itacitinib in Combination With Everolimus in Terms of Duration of Response.

    Measured: 2 years

  5. Determine the Efficacy of Itacitinib in Combination With Everolimus in Terms of Progression Free Survival (PFS).

    Measured: 2 years

  6. Determine the Efficacy of Itacitinib in Combination With Everolimus in Terms of Overall Survival (OS).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start11 Feb 2019
  3. Primary completion20 May 2024
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697408
Sponsor's protocol ID
IRB # 831774; UPCC #45418
Status last verified
Jun 2026
First submitted
28 Sep 2018
Last updated
23 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Itacitinib and Everolimus in people with Classical Hodgkin Lymphoma, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II: Efficacy of Itacitinib in Combination With Everolimus (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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