Your session is about to expire
← Back to Search
Janus Kinase (JAK) Inhibitor
Itacitinib for Bronchiolitis Obliterans Syndrome
Phase 1
Recruiting
Led By Amin Alousi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male patients must be willing to refrain from donating sperm during their participation in the study and for at least 3 months after completing the study.
Age 18-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 3 and 6 months
Awards & highlights
Study Summary
This trial tests how well itacitinib works to treat bronchiolitis obliterans syndrome, a lung condition, after a donor hematopoietic cell transplant.
Who is the study for?
Adults aged 18-75 who've had a donor stem cell transplant and are now facing a lung condition called bronchiolitis obliterans syndrome (BOS) can join. They need to be in decent health otherwise, with specific blood counts, and able to understand the study. Women of childbearing age must not be pregnant or nursing, and all participants should avoid having children during the trial.Check my eligibility
What is being tested?
The trial is testing Itacitinib's effectiveness for BOS after stem cell transplants. This early-phase study will see if blocking certain enzymes with Itacitinib stops harmful cell growth that contributes to this lung condition.See study design
What are the potential side effects?
Itacitinib might cause side effects like changes in blood tests reflecting liver or kidney function, potential impact on blood cells leading to increased infection risk or bleeding problems, fatigue, nausea, or other symptoms as yet unknown due to its investigational nature.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to donate sperm during and for 3 months after the study.
Select...
I am between 18 and 75 years old.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I have had a stem cell transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib
Secondary outcome measures
Change in 6-minute walk test
Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies
Changes in National Institutes of Health (NIH) symptom-based lung score
+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: Treatment (itacitinib)Experimental Treatment2 Interventions
Patents receive itacitinib PO QD for up to 1 year in the absence of disease progression or unacceptable toxicity.
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?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,284 Total Patients Enrolled
1 Trials studying Bronchiolitis Obliterans
15 Patients Enrolled for Bronchiolitis Obliterans
Amin Alousi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
168 Total Patients Enrolled
Rohtesh S MehtaPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer came back after a stem cell transplant.I am using a highly effective birth control method.You have been diagnosed with BOS (Bronchiolitis Obliterans Syndrome) in the last 6 months, as defined by specific medical guidelines.I agree not to donate sperm during and for 3 months after the study.You are currently using a ventilator or your oxygen levels are consistently below 88%.I haven't taken JAK inhibitors like Ruxolitinib in the last 6 months.Your doctor expects you to live for less than 6 months.I am between 18 and 75 years old.I am a woman of childbearing age and have not had a positive pregnancy test.I am able to care for myself but may not be able to do active work.I do not have severe heart problems or other serious health issues unrelated to GVHD.I have never had progressive multifocal leukoencephalopathy.Your white blood cell count, red blood cell count, and platelet count are within certain healthy levels.I have had a stem cell transplant from a donor.I cannot perform lung function tests accurately.My kidney function is severely impaired.I had tuberculosis after my stem cell transplant.I do not have any ongoing serious infections.Your lung function is very low, less than 40% of what is expected.I have HIV or active hepatitis B or C.Your liver enzymes are more than 5 times the normal level.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (itacitinib)
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.
Do I satisfy the criteria to participate in this research?
"The trial is seeking 15 adults aged 18 to 75 suffering from bronchiolitis obliterans. To qualify, participants must have a Karnofsky performance score of at least 60 or higher."
Answered by AI
Are participants in this clinical trial still being onboarded?
"Affirmative. Clinicaltrials.gov suggests that enrollment for this study is ongoing since its initial post date of April 8th 2021 and last update of September 30th 2022. The trial seeks 15 volunteers from one location to participate in the experiment."
Answered by AI
Has this experiment been done before, or is it pioneering?
"Since 2013, Incyte Corporation has been researching Itacitinib and conducted a clinical trial involving 121 participants in the same year. This led to Phase 1 drug approval for Itacitinib, followed by 23 separate trials spread across 20 countries with 76 cities participating."
Answered by AI
Are there any precedents of Itacitinib being tested in a medical research setting?
"Presently, Itacitinib is the subject of 23 clinical trials with one trial in Phase 3. While Philadelphia, Pennsylvania hosts the bulk of these studies, a total of 397 sites are participating across all investigations."
Answered by AI
Is this research project open to individuals who have exceeded the age of 35?
"This research study is seeking out participants aged 18 and up to 75 years old."
Answered by AI
What is the maximum capacity for individuals to partake in this trial?
"Affirmative. Clinicaltrials.gov contains the information that this medical study, which was first exhibited on April 8th 2021, is currently enrolling volunteers. 15 participants need to be welcomed from 1 research facility."
Answered by AI
Are there any health hazards associated with Itacitinib treatment?
"Considering the limited amount of data backing up its safety and efficacy, Itacitinib has been rated a 1 on Power's scale."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger