Active not recruitingPHASE2INTERVENTIONAL

Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

This study is for people in the UK who have a type of blood cancer called B-cell malignancy and are already receiving treatment in a different research study with a drug called parsaclisib. It's designed to let them continue taking parsaclisib, either on its own or with other medicines like itacitinib, ruxolitinib, or ibrutinib, if their current treatment is working well and they are benefiting from it. This means if you are already getting good results and feel better on parsaclisib, this study allows you to keep getting the medicine. The main goal is to make sure you can continue your helpful treatment when it wouldn't be available outside a research study, and to keep an eye on safety.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Incyte Corporation

Enrolment target

112

Start

03 Aug 2020

Estimated completion

30 Sep 2027

B-Cell Malignancies

What is this study about?

This study is called a "rollover study." Imagine you're taking part in a research study with a new medicine called parsaclisib for your B-cell malignancy (a type of blood cancer). If that medicine is helping you and keeping your condition stable, you might worry about what happens when your current study ends. This rollover study is designed to make sure you can keep receiving parsaclisib if it's beneficial for you.

It's specifically for people who are already in an Incyte-sponsored study involving parsaclisib, either by itself or with other medicines like itacitinib, ruxolitinib, or ibrutinib. If your current doctors believe the treatment is working for you, and your condition hasn't gotten worse, this study provides a way for you to continue receiving the same medication at the same dose. This is important because, sometimes, new medicines are only available through research studies.

The main aim of this study is to ensure you can continue to benefit from parsaclisib if it's working for you, and to keep track of any side effects. It helps ensure that effective treatments remain available to patients who need them, even after the initial study finishes, especially when these treatments aren't yet widely available. This helps bridge the gap until the medicine might be approved and accessible more generally.

Key takeaways

This study is for continuing Parsaclisib treatment for B-cell malignancies.
It's only for people already in another Parsaclisib study.
You must be benefiting from current treatment and have stable disease.
Treatment dose and schedule will remain the same.
The main goal is to allow continued access to helpful medication.
Safety will continue to be closely monitored by your doctors.

Who may be eligible?

This study is specifically for certain people who are already taking part in another research study. To be considered, you must have a B-cell malignancy (a type of blood cancer) and currently be enrolled in an Incyte-sponsored clinical study where you are receiving parsaclisib, either on its own or with other drugs like itacitinib, ruxolitinib, or ibrutinib.

Your doctors must believe that your current treatment is helping you, and your condition should be stable (not getting worse). You also need to be able to cope with the treatment well and follow the study's instructions, including attending appointments and taking any other recommended medicines. You must be at least 18 years old. Also, if you are able to get parsaclisib outside of a research study, then this study is not for you.

You cannot join this study if you have already stopped your treatment in the original study for any reason, or if you are pregnant or breastfeeding. Also, if you have other health issues that your doctor thinks could make it unsafe for you to take part, or make it hard for you to follow the study rules, you would not be able to join.

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 in an Incyte-sponsored parsaclisib study?
Is your current parsaclisib treatment helping you, and is your condition stable?
Are you tolerating your current treatment well?
Are you aged 18 or over?
Are you willing and able to attend all study appointments and follow instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive Parsaclisib, either on its own or with Itacitinib, Ruxolitinib, or Ibrutinib, at the exact same dose and schedule you are currently on. You will likely continue with regular visits to the clinic, where doctors will check your general health, blood tests, and ask about any side effects you might be experiencing. These visits are important to make sure the treatment continues to be safe and effective for you. You will need to take medication to prevent a certain type of pneumonia (PJP prophylaxis) if you are not already doing so. The study will continue for an extended period, depending on whether the treatment continues to benefit you and whether the medication becomes available more widely.

Potential risks and benefits

The main benefit of joining this study is that you can continue your current treatment with parsaclisib if it is helping your B-cell malignancy and keeping your condition stable. This is especially helpful if the medicine isn't available outside of a research study. Like all medicines, parsaclisib and the combination drugs can have side effects, and the study will continue to monitor these very carefully. Your doctors will explain any known specific risks to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (105)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Uab Comprehensive Cancer Center
Verified postcode
Birmingham, United States
University of Alabama At Birmingham
Verified postcode
Birmingham, United States
Mayo Clinic Rochester
Verified postcode
Phoenix, United States
University of Arizona Cancer Center-Out Pt.
Verified postcode
Tucson, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
California Cancer Associates For Research and Excellence
Verified postcode
Fresno, United States
Innovative Clinical Research Institute
Verified postcode
Long Beach, United States
Rocky Mountain Cancer Center
Verified postcode
Aurora, United States
Rush University Medical Center-Consultants in Hematology
Verified postcode
Chicago, United States
University of Kansas Hospital Authority
Verified postcode
Westwood, United States
Rcca Md, Llc
Verified postcode
Bethesda, United States
Massachusetts General Hospital
Verified postcode
Boston, United States

Common questions

What is a 'rollover' study?

A rollover study allows people who are already getting good results from a medicine in one research study to continue receiving that medicine in a new study.

Why is this study happening?

It's to ensure that patients benefiting from parsaclisib in an ongoing study can keep getting the medicine, especially if it's not yet widely available outside of research.

What kind of cancer is this for?

This study is for people with B-cell malignancies, which are types of blood cancer.

Will my treatment change if I join?

No, you will stay on the exact same dose and schedule of parsaclisib (and any other medicines you're taking with it) as you are on in your current study.

What if the medicine stops working?

The study aims to provide continued treatment only if it's still benefiting you. If your condition worsens or the treatment is no longer effective, your doctor will discuss other options with you.