Itacitinib + Everolimus in Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Jan 6, 2027
  • participants needed
    28
  • sponsor
    University of Pennsylvania
Updated on 6 August 2021
platelet count
gonadotropin
cancer
hysterectomy
lymphoma
measurable disease
carcinoma
everolimus
gilbert's syndrome
cytopenia
neutrophil count
pembrolizumab
nivolumab
positron emission tomography/computed tomography
brentuximab
refractory classical hodgkin lymphoma

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).

Details
Condition Classical Hodgkin Lymphoma
Treatment Everolimus, itacitinib
Clinical Study IdentifierNCT03697408
SponsorUniversity of Pennsylvania
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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/L
Platelet count > 75,000/L
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 (-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

Exclusion Criteria

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
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)
Bilirubin < 3 ULN in the presence of liver metastases or presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia)
Has a history (within the past 12 months) of (non-infectious) pneumonitis requiring systemic steroids, or active pneumonitis
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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