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Janus Kinase Inhibitor

Ruxolitinib for Graft-versus-Host Disease

Q: For which demographics is enrollment in this trial open?

The clinical trial is currently permitting 46 minors and adults between 28 days and 18 years of age who are diagnosed with graft vs host disease to participate. Additionally, the following conditions must be fulfilled: The patient has not received any treatment for cGvHD except a maximum 72 hours of corticosteroids, OR they have had refractory moderate to severe cGvHD while receiving systemic steroids for less than 18 months prior to Cycle 1 Day 1, or else having undergone allogeneic stem cell transplantation from bone marrow, peripheral blood cells or cord blood in myeloablative or reduced intensity conditioning regimens. In addition, both

Q: What maladies does INC424 typically alleviate?

INC424 is a widely-used treatment for <a href="https://www.withpower.com/clinical-trials/polycythemia-vera">polycythemia vera</a> and also prescribed to address hydroxyurea resistant or intolerant polycythaemia, as well as primary <a href="https://www.withpower.com/clinical-trials/myelofibrosis">myelofibrosis</a>.

Q: Are there still openings for participation in this clinical experiment?

We can find that, according to clinicaltrials.gov, no more participants are being enrolled for this trial which was initially posted on May 20th 2020 and revised most recently on October 26th 2022. Fortunately though, there is still an abundance of other medical studies actively accepting patients at the moment - 266 in total.

Q: To what extent might INC424 pose a hazard to human health?

While there is clinical evidence of INC424's safety, it has yet to be demonstrated as effective. Therefore, on a scale from 1 to 3, our team at Power have assigned this medication a score of 2.

Q: Is the age requirement for this clinical study limited to those over 70?

As outlined in the entrance requirements, this trial has a minimum age of 4 weeks and maximum age of 18 years.

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects age ≥28 days and <18 years at the time of informed consent

Subjects who have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of myeloablative or reduced intensity conditioning are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to end of study treatment, up to 36 months

Awards & highlights

Study Summary

This trial will investigate the effects of a drug called ruxolitinib on children and adolescents with a certain type of medical condition. The trial will enroll around 42 subjects, and will look at the activity, safety, and how the body processes the drug in different age groups.

Who is the study for?

This trial is for infants, children, and adolescents aged ≥28 days to <18 years who have undergone a stem cell transplant and are now facing moderate to severe chronic Graft vs. Host Disease (cGvHD). They must not have received extensive treatment for cGvHD before, except possibly some corticosteroids. Participants should not have certain bone disorders, uncontrolled infections or liver diseases, known HIV/HBV/HCV infection, or be on recent calcineurin inhibitors.Check my eligibility

What is being tested?

The study tests the drug ruxolitinib in young patients with cGvHD post-stem cell transplant. It's an open-label Phase II trial where all participants receive the drug alongside their standard immunosuppressive treatments. The effects of ruxolitinib will be monitored across different age groups ranging from infants to teenagers.See study design

What are the potential side effects?

Ruxolitinib may cause side effects such as risk of infections due to immune system suppression, potential blood count changes leading to anemia or increased bleeding risk, and possible liver function abnormalities. Other less common side effects might include headaches and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18 years old and older than 28 days.

Select...

I have received a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to end of study treatment, up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to end of study treatment, up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to end of study treatment, up to 36 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

Overall response rate (ORR)

Secondary outcome measures

Best overall response (BOR)

Cumulative incidence of malignancy relapse/recurrence (MR)

Duration of response (DOR)

+8 more

Side effects data

From 2014 Phase 4 trial • 48 Patients • NCT01558739

42%

Anaemia

35%

Thrombocytopenia

25%

Epistaxis

23%

Fatigue

23%

Headache

23%

Contusion

23%

Diarrhoea

23%

Abdominal pain

21%

Lethargy

19%

Dizziness

17%

Urinary tract infection

15%

Muscle spasms

15%

Lower respiratory tract infection

15%

Nausea

13%

Back pain

13%

Fall

13%

Night sweats

13%

Dyspnoea

10%

Pyrexia

10%

Gout

10%

Upper respiratory tract infection

10%

Pruritus

10%

Cough

Mouth ulceration

Alanine aminotransferase increased

Arthralgia

Pain in extremity

Vomiting

Constipation

Depression

Alopecia

Platelet count decreased

Abdominal pain upper

Hyperhidrosis

Weight increased

Flank pain

Nasopharyngitis

Paraesthesia

Neutropenia

Abdominal distension

Staphylococcal sepsis

Splenomegaly

VIIth nerve paralysis

Dysarthria

Dysphagia

Febrile neutropenia

Bronchopneumonia

Infected skin ulcer

Kidney infection

Chronic obstructive pulmonary disease

Progressive multifocal leukoencephalopathy

Renal impairment

Disorientation

Skin lesion

Migraine

Atrial fibrillation

Hernia

Cataract

Eyelid ptosis

Cataract operation

100%

80%

60%

40%

20%

Study treatment Arm

INC424

Trial Design

1Treatment groups

Experimental Treatment

Group I: INC424 (ruxolitinib)Experimental Treatment1 Intervention

Subjects who will be administered 5mg ruxolitinib tablet or ruxolitinib oral pediatric formulation twice a day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INC424

2011

Completed Phase 4

~2340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,856 Previous Clinical Trials

4,197,659 Total Patients Enrolled

1 Trials studying Graft-versus-Host Disease

127 Patients Enrolled for Graft-versus-Host Disease

Media Library

Ruxolitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03774082 — Phase 2

Graft-versus-Host Disease Research Study Groups: INC424 (ruxolitinib)

Graft-versus-Host Disease Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT03774082 — Phase 2

Ruxolitinib (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03774082 — Phase 2

Frequently Asked Questions

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

For which demographics is enrollment in this trial open?

"The clinical trial is currently permitting 46 minors and adults between 28 days and 18 years of age who are diagnosed with graft vs host disease to participate. Additionally, the following conditions must be fulfilled: The patient has not received any treatment for cGvHD except a maximum 72 hours of corticosteroids, OR they have had refractory moderate to severe cGvHD while receiving systemic steroids for less than 18 months prior to Cycle 1 Day 1, or else having undergone allogeneic stem cell transplantation from bone marrow, peripheral blood cells or cord blood in myeloablative or reduced intensity conditioning regimens. In addition, both"

Answered by AI

What maladies does INC424 typically alleviate?

"INC424 is a widely-used treatment for polycythemia vera and also prescribed to address hydroxyurea resistant or intolerant polycythaemia, as well as primary myelofibrosis."

Answered by AI

Are there still openings for participation in this clinical experiment?

"We can find that, according to clinicaltrials.gov, no more participants are being enrolled for this trial which was initially posted on May 20th 2020 and revised most recently on October 26th 2022. Fortunately though, there is still an abundance of other medical studies actively accepting patients at the moment - 266 in total."

Answered by AI

To what extent might INC424 pose a hazard to human health?

"While there is clinical evidence of INC424's safety, it has yet to be demonstrated as effective. Therefore, on a scale from 1 to 3, our team at Power have assigned this medication a score of 2."

Answered by AI