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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can obtain everolimus through my insurance or by paying myself.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.
Select...
My Hodgkin lymphoma has returned after treatment.
Select...
I have a tumor that can be measured on scans, being at least 15mm long or 10mm wide.
Select...
My disease came back or didn't respond after 2 treatments and I can't have high-dose therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Collection of dose-limiting toxicities of combination treatment with itacitinib and everolimus.
Phase II: Efficacy of itacitinib in combination with everolimus
Secondary outcome measures
Determine the efficacy of itacitinib in combination with everolimus in terms of Complete Response (CR).
Determine the efficacy of itacitinib in combination with everolimus in terms of Overall Response Rate (ORR).
Determine the efficacy of itacitinib in combination with everolimus in terms of Partial Response (PR).
+4 moreSide effects data
From 2020 Phase 3 trial • 439 Patients • NCT0313960434%
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%
Blood cholesterol increased
7%
Hypotension
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
Placebo Plus Corticosteroids
Itacitinib Plus Corticosteroids
Total
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
~910
Everolimus
2010
Completed Phase 4
~1510
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,065 Total Patients Enrolled
Jakub Svoboda, MDPrincipal InvestigatorUniversity of Pennsylvania
6 Previous Clinical Trials
149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can obtain everolimus through my insurance or by paying myself.I can take care of myself and am up and about more than half of my waking hours.I am not pregnant and agree to use birth control.I have been cancer-free from other types of cancer for at least 2 years.I am not using other cancer treatments while in this study.I can understand and agree to the study's consent form.I am 18 years old or older.I do not have severe heart, lung, liver issues, infections, or specific medication use.I haven't used any experimental drugs or therapies in the last 28 days.My Hodgkin lymphoma has returned after treatment.I have a tumor that can be measured on scans, being at least 15mm long or 10mm wide.My disease came back or didn't respond after 2 treatments and I can't have high-dose therapy.I am unable to sign the consent form myself.I have used JAK1 inhibitor or had cancer progress on everolimus.I agree to use contraception if my partner can become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Itacitinib and everolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical maladies commonly respond to Itacitinib?
"Itacitinib is a powerful treatment for kidney transplant rejection as well as Waldenstrom macroglobulinemia, lung afflictions, and advanced carcinoid tumor."
Answered by AI
What is the upper bound of enrollees for this experiment?
"This research is no longer recruiting participants. Initially shared on February 11th 2019, the trial was most recently updated November 28th 2022. If you are searching for other trials, there are presently 1725 investigations seeking patients with classical hodgkin's lymphoma and 114 studies examining Itacitinib that need volunteers to continue their work."
Answered by AI
Are any openings available to participate in this clinical investigation?
"Clinicaltrials.gov documents that this trial is no longer enrolling participants; the study was posted on February 11th 2019 and most recently edited on November 28th 2022. Nonetheless, there are still 1,839 other trials seeking candidates at present time."
Answered by AI
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