Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A phase I/II trial of Obinutuzumab, ABT-199 (GDC-0199) plus Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma patients (OAsIs)

This research study, called OAsIs, is looking into new ways to treat a type of blood cancer called Mantle Cell Lymphoma. This is for UK patients whose cancer has either returned after initial treatment or didn't respond well to it. The study is particularly interested in combining three specific medicines: Ibrutinib, Obinutuzumab, and GDC-0199. It's split into two main parts. The first part, Phase I, focuses on finding the safest combination and dosage of these drugs. The second part, Phase II, then looks at how effective this safe combination is at treating the cancer. Researchers will carefully check for any side effects and see how the cancer responds over time.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Hospitalier Universitaire De Nantes

Enrolment target

Start

18 Oct 2024

Patients with relapsed / refractory Mantle Cell Lymphoma

What is this study about?

This clinical trial is for people in the UK who have been diagnosed with Mantle Cell Lymphoma. This is a type of cancer that affects white blood cells, and the study is focused on patients whose cancer has either come back after treatment or hasn't responded as expected to previous therapies.

The main goal of this study is to test new combinations of three different medicines: Ibrutinib, Obinutuzumab, and GDC-0199. Researchers want to understand how safe these drug combinations are when used together. They will be looking very closely at any side effects people might experience, especially during the early stages of treatment. They also want to see if these combinations can help control or reduce the cancer.

The study is divided into two phases. In Phase I, the team will carefully increase the doses of the medicines to find a combination that is safe and tolerable for patients. Once a safe combination is identified, Phase II will then focus on how well this specific combination works against the cancer. This includes looking at whether the cancer shrinks or stops growing, and how long people stay well after treatment.

Key takeaways

This study is for adults with Mantle Cell Lymphoma that has come back or not responded to past treatments.
It's testing combinations of Ibrutinib, Obinutuzumab, and GDC-0199.
The main goals are to check the safety and effectiveness of these new drug combinations.
Participation involves regular hospital visits for monitoring and receiving study drugs.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.

Crucially, you must have been diagnosed with Mantle Cell Lymphoma that has either returned after you've already had treatment or hasn't responded to previous treatments. This means the study is specifically for people whose cancer is proving challenging to treat with standard methods.

Beyond these general points, there will be other specific health requirements and medical tests that doctors will need to check to make sure the study is a safe and suitable option for you. Your blood test results, overall health, and any other medical conditions will be carefully reviewed.

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 18 years old or older?
Have you been diagnosed with Mantle Cell Lymphoma?
Has your Mantle Cell Lymphoma returned after treatment, or did it not respond to previous treatments?
Are you able to attend regular hospital appointments for monitoring and treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have blood tests, physical examinations, and other checks to see how you are responding to the medicines and to monitor for any side effects. You would receive the study medications, Ibrutinib, Obinutuzumab, and GDC-0199, as prescribed by the study doctors.

Initially, the focus is on monitoring closely in the first few cycles of treatment (a cycle of treatment usually lasts a specific number of weeks). After this initial period, you would continue to be monitored throughout your treatment and likely for a period afterwards to track your health and the cancer's response. The total duration of your participation would depend on how your body responds to the treatment and the study's design, which your doctor can explain in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as gaining access to new drug combinations for Mantle Cell Lymphoma that are not yet widely available. These combinations might help control your cancer. However, like all medicines, these drugs can have side effects, and some could be serious. The study team will monitor you very closely for any potential risks or side effects. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
France

Common questions

What is Mantle Cell Lymphoma?

It's a rare type of blood cancer that affects white blood cells called lymphocytes, which are part of your immune system.

What does 'relapsed/refractory' mean?

Relapsed means your cancer has returned after treatment. Refractory means your cancer didn't respond to previous treatments.

Are these new medicines or ones already used?

The medicines Ibrutinib and Obinutuzumab are already used for some cancers, but they are being tested here in new combinations, and GDC-0199 is also being investigated alongside them.

What does 'Phase I/II' mean for me?

Phase I trials are about finding the safest dose, and Phase II trials are about seeing how well the treatment works at that safe dose. This study combines both, meaning there's a strong focus on safety first.

Who can I talk to if I'm interested?

If you think this study might be for you, the best person to speak to is your own cancer doctor or specialist. They can review your case and discuss if it's a suitable option.