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Janus Kinase (JAK) Inhibitor

Itacitinib for Graft-versus-Host Disease (GVHD Trial)

Phase 1
Waitlist Available
Led By Markus Mapara, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to swallow oral medication
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights

GVHD Trial Summary

This trial is designed to assess the safety and effectiveness of a combination of two drugs to treat patients with a specific kind of graft versus host disease that has not responded to steroids. The secondary objectives are to estimate response rates, time to response, duration of response, and progression-free survival, among other things.

Eligible Conditions
  • Steroid Refractory Graft-versus-Host Disease
  • Graft-versus-Host Disease

GVHD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to swallow pills.

GVHD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Access Safety and Tolerability
MTD of Tocilizumab IV infusion when given with Itacitinib
Secondary outcome measures
Duration of Response
Incidence of Disease Relapse
Incidence of Infections
+5 more

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
33%
Thrombocytopenia
27%
Anaemia
25%
Oedema peripheral
23%
Hyperglycaemia
20%
Diarrhoea
18%
Hypertension
18%
Neutropenia
17%
Cough
17%
Hypokalaemia
16%
Nausea
15%
Pyrexia
15%
Fatigue
14%
Cytomegalovirus viraemia
14%
Platelet count decreased
13%
Hypertriglyceridaemia
12%
Abdominal pain
12%
Alanine aminotransferase increased
12%
Cytomegalovirus infection reactivation
12%
Headache
11%
Vomiting
11%
Constipation
11%
Decreased appetite
11%
Insomnia
11%
Hypomagnesaemia
11%
Tremor
10%
Arthralgia
10%
Blood creatinine increased
10%
Dyspnoea
10%
Fall
10%
Muscular weakness
9%
Dizziness
9%
Back pain
9%
Hyponatraemia
8%
Dry eye
8%
Hypoalbuminaemia
8%
Hypocalcaemia
8%
Upper respiratory tract infection
8%
Aspartate aminotransferase increased
7%
Asthenia
7%
Anxiety
7%
Urinary tract infection
7%
Pruritus
7%
Dry mouth
7%
Acute kidney injury
6%
Hypophosphataemia
6%
Pneumonia
6%
Blood alkaline phosphatase increased
6%
Blood cholesterol increased
6%
Dysuria
6%
Hyperkalaemia
6%
Pain in extremity
6%
Hypotension
6%
Neutrophil count decreased
6%
Cytomegalovirus infection
5%
Dyspepsia
5%
Oedema
5%
Epistaxis
5%
White blood cell count decreased
5%
Oral candidiasis
5%
Rhinorrhoea
4%
Neuropathy peripheral
4%
Nasopharyngitis
4%
Gamma-glutamyltransferase increased
4%
Epstein-Barr virus infection reactivation
4%
Leukopenia
4%
Pancytopenia
4%
Vision blurred
4%
Weight decreased
4%
Dry skin
3%
Dysgeusia
3%
Febrile neutropenia
3%
Sepsis
3%
Rash
2%
Graft versus host disease in gastrointestinal tract
2%
Respiratory failure
2%
Septic shock
1%
Bacteraemia
1%
Enterococcal bacteraemia
1%
Influenza
1%
Graft versus host disease
1%
Pulmonary embolism
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Bronchitis
1%
Bronchopulmonary aspergillosis
1%
Confusional state
1%
Dehydration
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Malignant neoplasm progression
1%
Multiple organ dysfunction syndrome
1%
Myopathy
1%
Presyncope
1%
Syncope
1%
Thrombotic microangiopathy
1%
Failure to thrive
1%
Acute graft versus host disease
1%
Cystitis haemorrhagic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Corticosteroids
Total
Itacitinib Plus Corticosteroids

GVHD Trial Design

2Treatment groups
Experimental Treatment
Group I: Itacitinib + TocilizumabExperimental Treatment2 Interventions
A dose de-escalation design will be used to identify the MTD of both itacitinib and tocilizumab when given in combination. The following two levels will be tested with at least 6 patients per dose: Dose level 1: Itacitinib 200 mg daily + tocilizumab 8mg/kg on cycle 1, day 1 (can repeat cycle 2 day 1 if Partial Response (PR) - Starting dose level Dose level -1: Itacitinib 200 mg daily + tocilizumab 4mg/kg on cycle 1, day 1 (can repeat cycle 2 day 1 if Partial Response (PR) - Dose De-escalation level Itacitinib will be given daily in 28-day long cycles, tocilizumab will be given every 4 weeks in 28-day cycles.
Group II: Dose ExpansionExperimental Treatment2 Interventions
Once the MTD is determined, an additional 10 patients as an expansion cohort to further define the safety profile of the combination and estimate its response rate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Itacitinib
2020
Completed Phase 3
~910

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,473,026 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
361 Previous Clinical Trials
55,049 Total Patients Enrolled
Amer AssalLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications for participating in this medical research?

"Inclusion into this trial requires that patients have the specified disease and be within a certain age range (18-99). Currently, around 24 volunteers are being sought."

Answered by AI

Are participants currently being sought for this medical research?

"Confirmed. According to the clinicaltrials.gov website, this medical trial is currently accepting applications from participants; it was initially posted on January 20th 2020 and updated most recently on April 28th 2022. A total of 24 individuals are needed at 2 sites for enrollment in the study."

Answered by AI

What precedent has been established with other experiments concerning Itacitinib?

"Currently, there are 93 trials being conducted on Itacitinib. Of those studies, 9 have reached Phase 3 status. Most of the locations conducting clinical research with this medication are in Poznan and New york; however, a total of 1850 sites around the world are participating in these trials."

Answered by AI

Are elderly persons excluded from this investigation?

"The requirements for this trial state that applicants must be within the 18-99 year old age range. There are 74 trials open to those underage and 231 specifically targeting seniors above 65 years of age."

Answered by AI

What is the intended outcome of this research project?

"Incyte Corporation, the clinical trial sponsor, reported that the primary evaluation metric is Access Safety and Tolerability. This measurement will be taken 28 to 35 days after End-of-Treatment (EOT) or last dose of study drug. Secondary outcomes include Incidence of Infections, Proportion of Patients Discontinuing Steroids, and Incidence of Disease Relapse."

Answered by AI

What conditions does Itacitinib commonly address?

"Itacitinib is most commonly prescribed for polyarticular juvenile idiopathic arthritis, but can provide relief to those suffering from sjia, cytokine release syndrome due to CAR-T therapy, and giant cells."

Answered by AI

What is the magnitude of participation in this medical research?

"Affirmative. Clinicaltrials.gov displays that this investigation, which was initially published on January 20th 2020, is currently enrolling participants. 24 individuals must be sourced from two distinct medical centers."

Answered by AI

Has the FDA approved Itacitinib for use in clinical practice?

"As the trial is still in its first phase, safety and efficacy data remains relatively minimal; thus, this drug was given a rating of 1."

Answered by AI
~0 spots leftby Mar 2025