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Janus Kinase (JAK) Inhibitor

Itacitinib for Bronchiolitis Obliterans Syndrome

Phase 1
Waitlist Available
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
Must not have
Relapsed primary malignancy for which SCT was performed
Prior treatment with any other JAK inhibitor (including Ruxolitinib) for BOS or any other indication within the past 6 months of enrolment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 and 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I agree not to donate sperm during and for 3 months after the study.
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I am between 18 and 75 years old.
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I am able to care for myself but may not be able to do active work.
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I have had a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer came back after a stem cell transplant.
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I haven't taken JAK inhibitors like Ruxolitinib in the last 6 months.
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I do not have severe heart problems or other serious health issues unrelated to GVHD.
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I am a woman of childbearing age and have not had a positive pregnancy test.
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I have never had progressive multifocal leukoencephalopathy.
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I cannot perform lung function tests accurately.
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My kidney function is severely impaired.
Select...
I had tuberculosis after my stem cell transplant.
Select...
I do not have any ongoing serious infections.
Select...
I have HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib
Secondary study objectives
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
Failure-free survival
+3 more

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: 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
~980

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,800 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

Itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04239989 — Phase 1
Bronchiolitis Obliterans Research Study Groups: Treatment (itacitinib)
Bronchiolitis Obliterans Clinical Trial 2023: Itacitinib Highlights & Side Effects. Trial Name: NCT04239989 — Phase 1
Itacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04239989 — Phase 1
~1 spots leftby May 2025
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