RecruitingPHASE3INTERVENTIONAL

A Long-term Extension Study of PCI-32765 (Ibrutinib)

This study is for people who are already taking a medicine called ibrutinib as part of an earlier clinical trial for conditions like chronic lymphocytic leukemia or mantle cell lymphoma, and are still finding it helpful. The main goals are to let these participants continue receiving ibrutinib and to keep track of how well it works and if there are any side effects over a longer period. It's an important step to ensure patients who benefit from ibrutinib can continue their treatment while helping researchers understand its long-term effects. This is not a study where you are randomly assigned to a new treatment; you'll continue with your current ibrutinib dose.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

700

Start

09 Sep 2013

Estimated completion

31 Aug 2027

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Waldenstrom Macroglobulinemia Chronic Graft Versus Host Disease

What is this study about?

This study is an extension of previous research involving a medicine called ibrutinib. It's designed specifically for people who have been taking ibrutinib in an earlier clinical trial for conditions such as chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, Waldenstrom macroglobulinemia, or chronic graft versus host disease. The main purpose is to allow those who are still benefiting from ibrutinib to continue their treatment.

Think of it as continuing care for patients who are doing well on ibrutinib. It also helps doctors collect more long-term information about the medicine. They want to understand better how safe ibrutinib is over many months or years and how well it continues to work. This kind of long-term data is really important for medicines that patients might take for a long time.

There isn't a new treatment being tested here. Instead, participants will continue with the same dose of ibrutinib they were taking before. Doctors will closely watch how you're doing and look for any side effects. This study aims to ensure that people who need ibrutinib can keep getting it, especially if other ways to access the medicine aren't yet available.

Key takeaways

This study offers continued access to ibrutinib for patients already benefiting from it.
It helps gather long-term information on ibrutinib's safety and effectiveness.
You will continue with your current ibrutinib dose.
Regular check-ups will monitor your health and any side effects.
You can leave the study at any time.
It's for people already in a finished ibrutinib trial for specific blood conditions.

Who may be eligible?

To join this study, you must already be taking ibrutinib as part of a previous clinical trial that has finished, and you need to have been on the treatment for at least six months. The doctors overseeing the study need to believe that continuing with ibrutinib will be more helpful than harmful for you. You also need to agree to use effective contraception if needed, and women must have a negative pregnancy test.

You would not be able to join if you are taking blood thinners like warfarin, or certain strong medications that can affect how ibrutinib works. Also, if your doctor thinks there's anything else that might put you at risk or make it hard to understand the study results, you might not be able to take part. This ensures the study is as safe as possible for everyone involved.

Quick self-check

Are you currently taking ibrutinib as part of an earlier clinical trial?
Have you been on ibrutinib for at least 6 months in that study (or just started if you crossed over)?
Does your doctor think you are still benefiting from ibrutinib?
Do you use effective contraception (if applicable)?
Are you NOT taking warfarin or strong medications that interfere with ibrutinib?
Are you comfortable with ongoing monitoring for a longer period?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue taking ibrutinib at the same dose you were on in your previous study. Your doctors will know you are taking ibrutinib – this isn't a 'blinded' study. You will have regular check-ups to make sure the medicine is still working well and to look for any side effects. These visits will likely involve tests like blood samples and physical exams.

You will continue treatment for as long as your doctor believes it is helping you, and you are not having side effects that are too difficult to manage. You might also stop treatment if you can get ibrutinib through other means, like a patient support program. The study will end either when all participants have moved on from study treatment, or if the study organisers decide to stop it. The total duration of your participation will depend on these factors.

Potential risks and benefits

The main benefit of joining this study is that you can continue to receive ibrutinib, a treatment that has been helping you, especially if you wouldn't be able to get it otherwise. This means you can keep benefiting from the drug's effects on your condition. As with any medicine, there are potential risks, including side effects from ibrutinib, which your doctors will monitor closely. They will also make sure that continuing treatment still offers more good than harm. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (175)

City of Hope Cancer Center
Duarte, United States· Completed
University of California San Diego Medical Center
La Jolla, United States· Completed
University of California Los Angeles
Los Angeles, United States· Completed
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, United States· Recruiting
Stanford University Medical Center
Stanford, United States· Completed
Stanford University
Stanford, United States· Completed
Norwalk Medical Group
Norwalk, United States· Completed
Northwest Georgia Oncology Centers PC
Marietta, United States· Completed
Northwestern University Hospital
Chicago, United States· Completed
Indiana University
Goshen, United States· Completed
Kansas University Medical Center
Westwood, United States· Completed
Louisville Oncology Suburban - Norton Cancer Institute
Louisville, United States· Completed

+163 more sites — see the official record for the full list.

Common questions

What is ibrutinib?

Ibrutinib is a medicine that helps treat certain types of blood cancers, like some lymphomas and leukemias, and chronic graft versus host disease. It works by blocking a specific protein inside cells that helps cancer cells grow.

Why is this study being done?

This study allows people who are already benefiting from ibrutinib in an earlier clinical trial to continue receiving the treatment. It also helps doctors gather more information about its long-term safety and how well it works over time.

Will I get a different dose of ibrutinib?

No, you will continue with the same dose of ibrutinib that you were taking in your previous study.

How long will I be in the study?

You will participate for as long as ibrutinib continues to help you and you don't have severe side effects. You might also stop if you can get the drug another way, or when the study itself finishes.

What happens if I decide to leave the study?

You are free to leave the study at any time, for any reason. Your decision will not affect your regular medical care.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.