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Itacitinib + ECP for Chronic Graft-versus-Host Disease (FLIGHT Trial)
Phase 2
Waitlist Available
Led By Catherine Lee, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks and 1 year
Awards & highlights
FLIGHT Trial Summary
This trial is designed to assess the recommended phase 2 dose (RP2D) of itacitinib in combination ECP and efficacy of the combination after 24 weeks of therapy.
Who is the study for?
Adults over 18 with moderate or severe chronic GVHD after a stem cell transplant, needing systemic treatment but haven't had any for chronic GVHD yet. They should be able to take oral meds, have stable organ function and blood counts, not be pregnant or breastfeeding, and willing to avoid pregnancy or fathering children.Check my eligibility
What is being tested?
The trial is testing Itacitinib in combination with ECP as a first-line treatment for chronic GVHD. It's an open-label Phase II study that will determine the best dose of Itacitinib (RP2D) using a '3+3' method and then assess its safety and effectiveness at this dose over 24 weeks.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system suppression such as increased risk of infections, potential liver issues indicated by changes in blood tests, gastrointestinal symptoms like nausea or diarrhea, skin reactions from ECP treatment, and general fatigue.
FLIGHT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks and 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Count of Participants With a Dose-limiting Toxicity (DLT) During the DLT Evaluation Period.
Count of Participants With a Response to Treatment at 24 Weeks of Treatment
Secondary outcome measures
Count of Participants Alive at 24 Weeks and 1 Year
Count of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) During Study Treatment
Count of Participants Who Have Withdrawn All Immunosuppressants at 1 Year
+12 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
FLIGHT Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment2 Interventions
Patients will self-administer itacitinib every morning regardless of food. ECP will be administered twice weekly on consecutive days for 8 weeks per institutional standards. At the end of 8 weeks of combination therapy, patients will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion as described below.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,627 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,162 Total Patients Enrolled
Catherine Lee, MDPrincipal InvestigatorHuntsman Cancer Institute
2 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform regular daily activities without much difficulty.You have uncontrolled symptoms of acute GVHD.You have severe lung problems or a specific lung condition confirmed by a biopsy.You are expected to live for at least 24 weeks.You have a condition in your upper digestive system that makes it hard for you to swallow pills or food.You have not received any treatment for chronic GVHD before starting the trial, except for certain medications that are allowed.You can swallow pills and keep them down.You have taken JAK inhibitor medication within the last 4 weeks before starting the trial.You have had a different type of cancer in the past, with some specific exceptions.You have moderate or severe chronic graft-versus-host disease (GVHD) as diagnosed by a doctor.You have had a specific type of stem cell transplant from a donor.You are currently receiving treatment for chronic GVHD as determined by your doctor.You have a cancer that has come back or is getting worse, or you have a type of disease that can happen after an organ transplant.You can use creams or inhalers for chronic GVHD, but if you had a specific treatment for acute GVHD called ECP, it must have been done more than 4 weeks before starting itacitinib treatment.You haven't received certain types of treatment for a specific condition for at least two weeks before starting the study. If you're taking certain medications to prevent or treat another condition, the dosage must be stable for at least two weeks before starting the study.Your liver, kidney, and blood clotting functions are within normal range, or if there are abnormalities, they are not related to a specific medical condition. If you are taking warfarin or similar medications, your blood clotting levels are within a certain range.You have a certain type of chronic complication after a specific treatment, but if you had a different treatment, you can still participate.You have a medical reason that makes it unsafe for you to have extracorporeal photopheresis (ECP), as decided by the doctor in charge.Your blood has to have a certain amount of white blood cells and platelets. You can't have received certain treatments to increase these levels within 7 days before the screening.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
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 is the total headcount of participants involved in this trial?
"Affirmative. According to clinicaltrials.gov, the search for participants is still in effect since the first post was made on January 29th 2021 and updated lastly on May 3rd 2022. This trial requires 58 individuals at a single site."
Answered by AI
Is there currently an opportunity to join this research endeavor?
"According to clinicaltrials.gov, this study is in the process of recruiting participants--the initial posting date was on January 29th 2021 and it has been most recently amended as of May 3rd 2022."
Answered by AI
To what extent is Itacitinib hazardous to the health of individuals?
"Due to the lack of existing clinical evidence regarding efficacy, Itacitinib was classified as a level 2 on our safety scale. This is because this trial only has Phase 2 data which suggests it meets minimal standards for safety."
Answered by AI
What results are hoped to be achieved in this research endeavor?
"The primary objective of this clinical trial, which will be measured across a 35-day period, is to gauge the overall response rate (ORR) at 24 weeks and Cycle 7 Day 1 visit. This ORR includes complete remission plus partial remission without secondary systemic immunosuppressive therapy or recurrent malignancy/death occuring. Secondary objectives are organ-specific response rates at both 24 weeks and one year using the NIH Consensus Development Project Criteria as well as an assessment of long term efficacy by stratifying concurrent prednisone use into three different groups: 0 mg/kg/d, ≤ 0.25mg/kg/"
Answered by AI
Have there been any prior investigations into the therapeutic use of Itacitinib?
"Currently, 23 clinical trials are ongoing for Itacitinib. One of these studies is in its third phase. Although the focus has been on Pennsylvania and Philadelphia specifically, 397 sites worldwide have opened up studies to further explore this treatment's efficacy."
Answered by AI
Is this research groundbreaking in its field?
"The pharmaceutical company Incyte Corporation initiated the inaugural trial of Itacitinib in 2013. This initial study entailed 121 participants, and has since been followed by 23 other active trials throughout 76 cities across 20 nations. Due to its success, it was granted Phase 1 drug approval that same year."
Answered by AI
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