Active not recruitingPHASE4INTERVENTIONAL

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

This is a study for people who have been taking the medicine ibrutinib for conditions like lymphoma or graft-versus-host disease (GvHD). If you've been in a previous ibrutinib study, are still feeling better because of the medicine, and can't get ibrutinib through regular pharmacies, this study might be for you. It's designed to let you keep taking ibrutinib at the same dose you were on before. The main goal is to make sure you continue to have access to this important treatment and help doctors understand more about its benefits and any side effects over a longer period.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Pharmacyclics Switzerland GmbH

Enrolment target

297

Start

22 May 2017

Estimated completion

10 May 2027

Lymphoma, B-Cell Lymphoma, Non-Hodgkin Leukemia, B-cell Graft Vs Host Disease Solid Tumor

What is this study about?

Imagine you've been taking a medicine called ibrutinib for a serious condition like lymphoma (a type of cancer) or graft-versus-host disease (GvHD), and it's really helping you. You've been part of an earlier research study, but that study has now finished. What happens if you still need ibrutinib, it's working well, but you can't get it from your usual pharmacy, perhaps because it's not widely available yet for your specific condition or in your area?

This study, called an 'extended treatment protocol', is designed to help in just that situation. It's for people who have already been taking ibrutinib in a previous study, are still finding it beneficial, and are unable to access it commercially. Think of it as a way to continue your treatment while researchers gather more information on the long-term effects of ibrutinib.

The main aim is to make sure you keep receiving the medicine you need and benefit from. At the same time, doctors will continue to carefully monitor your health, looking for any side effects and tracking how well the medicine is working for you over a longer period. This information is very valuable for understanding ibrutinib better in the long run.

Key takeaways

Provides continued access to ibrutinib for eligible patients.
For those who previously benefited from ibrutinib in another study.
Specifically for patients who can't get the medicine commercially.
Involves ongoing monitoring for safety and effectiveness.
You stay on your current, effective dose of ibrutinib.
Helps gather long-term information on ibrutinib's use.

Who may be eligible?

This study is for adults who have already taken part in a previous study involving ibrutinib and are still benefiting from it. It's really important that your doctor believes you are getting a positive effect from the medicine.

You also need to be in a situation where you can't get ibrutinib through your usual health services or pharmacies in your local area. The study also requires you to have finished all the necessary check-ups and assessments from your previous ibrutinib study.

However, you won't be able to join if your previous study told you to stop taking ibrutinib permanently. You also can't be pregnant, breastfeeding, or planning to become a parent during the study and for 90 days afterwards. Finally, you need to be able to understand what the study involves and agree to take part voluntarily.

Quick self-check

Have I taken part in a previous ibrutinib study?
Do I still feel that ibrutinib is helping my condition?
Has my doctor confirmed I'm still benefiting from ibrutinib?
Can I not get ibrutinib through regular pharmacies or health services for my condition in my area?
Am I willing and able to attend all required appointments for monitoring?
Am I not pregnant, breastfeeding, or planning to become pregnant/father a child in the near future?

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'll continue taking ibrutinib by mouth, just like you did in your previous study. You'll take the same dose and follow the same schedule.

Your treatment will continue for as long as your doctors believe the medicine is still helping you. This might go on until ibrutinib becomes widely available for your condition through regular pharmacies. During this time, you will have regular check-ups, just like your usual doctor's appointments for your condition. Your medical team will monitor your general health, specifically looking for any side effects or new health issues that might pop up. They will record any side effects, whether they are mild or serious, and if they lead to changes in your dose or stopping the medicine. They will also note any pregnancies or other new health problems. The overall duration is not fixed, as it depends on your continued benefit from the medicine and its commercial availability.

Potential risks and benefits

The main benefit of joining this study is that you can continue to receive ibrutinib, a medicine that is currently helping you, especially if you can't get it elsewhere. This can help you manage your condition and maintain your quality of life. Like all medicines and studies, there are potential risks, mainly related to possible side effects of ibrutinib, which your doctor will discuss with you. Your doctors will carefully monitor you for any problems. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (98)

Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
Burbank, United States
City Of Hope National Medical Center
Duarte, United States
UCSD Moores Cancer Center
La Jolla, United States
University of California Los Angeles (UCLA)
Los Angeles, United States
Stanford University
Stanford, United States
Emory University
Atlanta, United States
Northwestern University
Chicago, United States
University of Chicago
Chicago, United States
Norton Medical Plaza II, 3991 Dutchmans Lane
Louisville, United States
Dana-Farber Cancer Institute
Boston, United States
Henry Ford Health System
Detroit, United States
TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, United States

+86 more sites — see the official record for the full list.

Common questions

What is ibrutinib?

Ibrutinib is a medicine used to treat certain types of blood cancers like lymphoma and a condition called graft-versus-host disease (GvHD).

Why is this study only for people who were in a previous ibrutinib study?

This study is designed to offer continued access to ibrutinib for people who are already benefiting from it but can no longer get it through their original study or regular pharmacies.

Will I get a different dose of ibrutinib in this study?

No, you will continue to receive ibrutinib at the same dose and on the same schedule that you were on at the end of your previous study.

How long will I be on the study medication?

You can continue taking ibrutinib as long as your doctors believe it's still benefiting you, or until the medicine becomes readily available for your condition outside of a study.

What kind of check-ups will I have?

You'll have regular medical check-ups and safety assessments, similar to the standard care you would receive for your condition.