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mTOR Inhibitor

Itacitinib + Everolimus for Hodgkin Lymphoma

Phase 1 & 2
Waitlist Available
Led By Jakub Svoboda, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have access to everolimus via insurance or self-pay
Performance status of ECOG 0-2
Must not have
Concurrent use of other anti-cancer agents or therapies during study treatment
Specific conditions such as symptomatic congestive heart failure, severe lung function impairment, active severe infections, liver disease, history of pneumonitis, concurrent use of certain medications, and viral infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of itacitinib in combination with everolimus in people with cHL that has relapsed or is resistant to treatment.

Who is the study for?
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.
What is being tested?
This study tests Itacitinib combined with Everolimus in patients with Hodgkin lymphoma that has come back or hasn't responded to treatment. It's an early-phase trial where everyone gets the same drugs to see how safe they are and if they work.
What are the potential side effects?
Potential side effects of Itacitinib and Everolimus may include risks like infection due to a weakened immune system, liver problems, lung issues such as pneumonitis (lung inflammation), digestive disturbances, blood cell count changes, fatigue, and possible heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can obtain everolimus through my insurance or by paying myself.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My Hodgkin lymphoma has returned after treatment.
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I have a tumor that can be measured on scans, being at least 15mm long or 10mm wide.
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My disease came back or didn't respond after 2 treatments and I can't have high-dose therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not using other cancer treatments while in this study.
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I do not have severe heart, lung, liver issues, infections, or specific medication use.
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I haven't used any experimental drugs or therapies in the last 28 days.
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I am unable to sign the consent form myself.
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I have used JAK1 inhibitor or had cancer progress on everolimus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: Collection of dose-limiting toxicities of combination treatment with itacitinib and everolimus.
Phase II: Efficacy of itacitinib in combination with everolimus

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
34%
Thrombocytopenia
29%
Anaemia
25%
Oedema peripheral
22%
Hyperglycaemia
21%
Hypertension
20%
Diarrhoea
19%
Hypokalaemia
18%
Platelet count decreased
18%
Nausea
17%
Neutropenia
16%
Cytomegalovirus viraemia
16%
Pyrexia
15%
Cough
14%
Alanine aminotransferase increased
14%
Hypertriglyceridaemia
13%
Dyspnoea
13%
Fatigue
13%
Hypomagnesaemia
13%
Tremor
12%
Cytomegalovirus infection reactivation
12%
Abdominal pain
12%
Blood creatinine increased
12%
Constipation
11%
Decreased appetite
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Dizziness
11%
Muscular weakness
11%
Vomiting
10%
Insomnia
9%
Fall
9%
Headache
8%
Upper respiratory tract infection
8%
Dry eye
8%
Dysuria
8%
Anxiety
8%
Back pain
7%
Hypotension
7%
Blood cholesterol increased
7%
Hyponatraemia
7%
Hypophosphataemia
7%
Pain in extremity
7%
Urinary tract infection
7%
Hypocalcaemia
7%
Neutrophil count decreased
7%
Dry mouth
7%
Cytomegalovirus infection
6%
Hypoalbuminaemia
6%
Pruritus
6%
White blood cell count decreased
6%
Asthenia
6%
Blood alkaline phosphatase increased
5%
Acute kidney injury
5%
Pneumonia
5%
Gamma-glutamyltransferase increased
5%
Oral candidiasis
5%
Rash
5%
Weight decreased
5%
Pancytopenia
5%
Dysgeusia
5%
Dyspepsia
5%
Epstein-Barr virus infection reactivation
4%
Hyperkalaemia
4%
Epistaxis
3%
Febrile neutropenia
3%
Oedema
3%
Rhinorrhoea
3%
Dry skin
3%
Leukopenia
3%
Nasopharyngitis
3%
Neuropathy peripheral
3%
Vision blurred
2%
Cystitis haemorrhagic
2%
Syncope
2%
Sepsis
1%
Graft versus host disease in gastrointestinal tract
1%
Thrombotic microangiopathy
1%
Viral haemorrhagic cystitis
1%
Bronchopulmonary aspergillosis
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Failure to thrive
1%
Malignant neoplasm progression
1%
Ophthalmic herpes zoster
1%
Oral herpes
1%
Pulmonary embolism
1%
Septic shock
1%
Pneumonia influenzal
1%
Myopathy
1%
Steroid diabetes
1%
Pseudomonal sepsis
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Itacitinib Plus Corticosteroids
Placebo Plus Corticosteroids
Total

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Itacitinib and everolimusExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~980
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,727,307 Total Patients Enrolled
Jakub Svoboda, MDPrincipal InvestigatorUniversity of Pennsylvania
6 Previous Clinical Trials
149 Total Patients Enrolled

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03697408 — Phase 1 & 2
Hodgkin's Lymphoma Research Study Groups: Itacitinib and everolimus
Hodgkin's Lymphoma Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT03697408 — Phase 1 & 2
Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03697408 — Phase 1 & 2
~3 spots leftby Dec 2025
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