Active not recruitingPHASE2INTERVENTIONAL

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

This study is a continuation plan for people currently participating in specific Incyte studies where they are treated with a drug called itacitinib. If you are already receiving itacitinib for conditions such as myelofibrosis (a bone marrow disorder), bronchiolitis obliterans after a lung transplant (a lung condition), or chronic graft-versus-host disease (a complication after stem cell or bone marrow transplants), and it's helping you and you're coping well with the treatment, you might be able to join. The main goal is to ensure you can keep receiving itacitinib at the same dose and schedule you're currently on. This rollover study aims to provide ongoing access to the treatment as long as your doctor believes it's beneficial and you continue to tolerate it without significant problems.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Incyte Corporation

Enrolment target

Start

10 Mar 2021

Estimated completion

22 Jun 2026

Myelofibrosis Postlung Transplant (Bronchiolitis Obliterans)Chronic Graft Versus Host Disease

What is this study about?

This study is designed to help people who are already taking a specific medication called itacitinib as part of an Incyte clinical trial. It's like a 'rollover' or continuation plan. If you've been in one of their previous studies for conditions like myelofibrosis (a blood cancer affecting the bone marrow), bronchiolitis obliterans (a serious lung problem that can happen after a lung transplant), or chronic graft-versus-host disease (a complex condition that can occur after a stem cell or bone marrow transplant), and you're finding that itacitinib is working for you and you're not having too many problems, then this study might be for you.

The main idea is to make sure you can keep receiving the medicine without interruption. You'll continue with the same dose and schedule you were on in your original study. This means you won't have to stop treatment if it's proving helpful and well-tolerated, which can be reassuring for patients who have found a beneficial treatment.

Your doctor will regularly assess how you're feeling and if the treatment is still providing a benefit. As long as the medication is helping you and you're tolerating it safely, you can continue in this study. The aim is to ensure a smooth and continued treatment path for those who need it.

Key takeaways

It's a continuation study for people already on itacitinib from specific clinical trials.
Allows ongoing access to treatment if it's beneficial and well-tolerated.
Your treatment dose and schedule will remain the same.
Requires regular check-ups and agreement from your doctor.
You must be 18 years or older.
You cannot be pregnant, breastfeeding, or able to get the drug commercially.

Who may be eligible?

To be considered for this study, you must already be taking itacitinib in a specific Incyte-sponsored study and finding that it's helping you. You also need to be coping well with the treatment, meaning you're not experiencing severe side effects or problems. Your doctor must agree that the treatment is still benefiting you.

It's important that you've been able to stick to the rules and appointments of your original study. You must also be willing to attend all scheduled visits for this new study and follow its treatment plan carefully. For women, this includes being willing to avoid getting pregnant, and for men, avoiding fathering children, while in the study and for a certain period afterward.

You cannot join this study if you can already get itacitinib from a pharmacy or your doctor as a standard treatment. Also, if you have other serious health problems that your doctor thinks would make taking part unsafe for you, or if you are pregnant or breastfeeding, you won't be able to join. All participants must be 18 years old or over and be able to understand and sign the consent form.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you currently receiving itacitinib in a specific Incyte clinical study?
Is the itacitinib treatment helping your condition?
Are you coping well with the treatment with no major side effects?
Are you 18 years old or older?
Are you able to attend all study appointments?
Are you not pregnant or breastfeeding, and willing to avoid pregnancy/fathering children during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the drug itacitinib at the same dose and schedule you had in your previous study. You'll need to attend regular visits with your study doctor and team. These visits will check how you are responding to the treatment and whether you are experiencing any side effects. The study team will monitor your health closely through check-ups, and possibly blood tests or other assessments, to make sure the treatment continues to be safe and effective for you. You can continue treatment as long as your doctor believes it's helping you, you're tolerating it well, and you don't meet any reasons to stop. The full duration will depend on these factors.

Potential risks and benefits

The main potential benefit of joining this study is the ability to continue receiving a treatment that your doctor believes is already helping you, without interruption. This can provide ongoing support for your condition. As with any medication, there are potential risks, which will be the same as those you experienced in your previous study with itacitinib. These risks should have been fully explained to you before, and the study team will monitor you closely for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (21)

City of Hope National Medical Center
Verified postcode
Duarte, United States
Anschutz Cancer Pavilion-University of Colorado
Verified postcode
Aurora, United States
Parkview Cancer Institute
Verified postcode
Fort Wayne, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States
Temple University Department of Thoracic Medicine and Surgery
Verified postcode
Philadelphia, United States
Sarah Cannon Research Institute
Verified postcode
Nashville, United States
Texas Oncology San Antonio
Verified postcode
San Antonio, United States
Ordensklinikum Linz Gmbh Elisabethinen
Verified postcode
Linz, Austria
Universitaire Ziekenhuis Leuven - Gasthuisberg
Verified postcode
Leuven, Belgium
Providence Health
Verified postcode
Vancouver, Canada
Universitatsklinikum Halle (Saale)
Verified postcode
Halle, Germany

Common questions

What is a 'rollover' study?

It's a study that allows you to continue receiving a medication you were taking in a previous clinical trial, if it was helping you and you were tolerating it well.

Why can't I just get itacitinib from my regular doctor?

This study is specifically for people where itacitinib isn't yet available commercially or as a standard treatment. If you could get it elsewhere, you wouldn't be eligible for this trial.

Will my treatment dose change in this study?

No, you will receive itacitinib at the same dose and on the same schedule you were on in your original clinical trial.

How long will I be in this study?

You can continue as long as the treatment is still benefiting you, you are tolerating it, and your doctor agrees it's appropriate to continue. There isn't a fixed end date for individuals.

What conditions is this study for?

This study is for people with myelofibrosis, bronchiolitis obliterans after a lung transplant, or chronic graft-versus-host disease, who were already receiving itacitinib for these conditions.