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

ROMIDEPSIN IN COMBINATION WITH CHOEP AS FIRST LINE TREATMENT BEFORE HEMATOPOIETIC STEM CELL TRANSPLANTATION IN YOUNG PATIENTS WITH NODAL PERIPHERAL T-CELL LYMPHOMAS: A PHASE I-II STUDY

This research is testing a new treatment for young people with specific types of T-cell lymphoma, a type of blood cancer. It combines a drug called Romidepsin with a common chemotherapy treatment called CHOEP. The study has two main parts. First, it will carefully check for side effects to find the safest dose of Romidepsin to use with CHOEP. This is called Phase I. Once a safe dose is found, the study will then look at how well this new combination treatment works to control the lymphoma before a stem cell transplant. This second part is called Phase II. The goal is to see if this new approach can help patients live longer without their cancer getting worse.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Fondazione Italiana Linfomi Ets

Enrolment target

125

Start

28 Oct 2024

Anaplastic Large T-cell Lymphoma ALK negative Angioimmunoblastic T-cell Lymphoma Peripheral T-cell lymphoma NOS

What is this study about?

This clinical trial is designed to investigate a new treatment approach for young people diagnosed with certain types of blood cancer known as T-cell lymphoma. Specifically, it focuses on conditions like Anaplastic Large T-cell Lymphoma (ALK negative), Angioimmunoblastic T-cell Lymphoma, and Peripheral T-cell Lymphoma (NOS). These are all types of lymphoma that affect a specific kind of white blood cell called T-cells.

The study combines a new drug called Romidepsin with a standard chemotherapy treatment known as CHOEP. This combination is given to patients before they undergo a stem cell transplant, which is a common and important treatment step for these types of lymphoma. The research is split into two phases. The first phase, called Phase I, is all about safety. Researchers will carefully increase the dose of Romidepsin, looking for any serious side effects to find the highest safe dose that can be given alongside CHOEP.

Once a safe dose is identified, the study moves into Phase II. In this part, the main goal is to see how effective the new Romidepsin-CHOEP combination is. Researchers will be looking at how long patients live without their disease getting worse (this is called 'PFS' – how long before the cancer progresses, returns, or the person sadly dies). They will also check how many patients respond to the treatment and the overall survival rates. By doing this, the researchers hope to find new and more effective ways to treat these challenging lymphomas.

Key takeaways

This study is testing a new drug, Romidepsin, with standard chemotherapy (CHOEP) for specific T-cell lymphomas.
It's for adults aged 18 and over, including older adults, with certain kinds of lymphoma.
The main goals are to find the safest dose of Romidepsin and see how well it works before a stem cell transplant.
Participation involves receiving treatment, regular hospital visits, and ongoing monitoring for side effects and treatment success.
This is a research study; potential benefits and risks will be discussed by your medical team.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate.

However, it's important to remember that this is a detailed study for specific types of lymphoma. The researchers are looking for people with Anaplastic Large T-cell Lymphoma (ALK negative), Angioimmunoblastic T-cell Lymphoma, or Peripheral T-cell Lymphoma, NOS. Your doctors will be able to tell you if your specific type of cancer fits these categories.

There will also be other medical checks and criteria that are not listed here, which your doctor will review to make sure this study is right and safe for you. It's always best to discuss your eligibility thoroughly with your healthcare team.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Anaplastic Large T-cell Lymphoma (ALK negative), Angioimmunoblastic T-cell Lymphoma, or Peripheral T-cell Lymphoma, NOS?
Are you able to undergo treatments like chemotherapy and potentially a stem cell transplant?
Are you willing to have regular medical checks and follow-up appointments?
Have your doctors confirmed that this specific type of study is suitable for your overall health?

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

What does participation involve?

If you decide to take part in this study, you will receive the study medication, Romidepsin, in combination with the standard CHOEP chemotherapy. This treatment will be given before you have your stem cell transplant. You will have regular hospital visits, especially during the treatment cycles, to receive your medication and have various tests. These tests will include blood samples and physical examinations to closely monitor how you are responding to the treatment and to check for any side effects.

The frequency of your visits and tests will depend on which part of the study you are in and where you are in your treatment cycle. After the main treatment, you will continue to have follow-up appointments. This is to keep track of your health long-term, monitor for any late side effects, and see how well the treatment continues to work over time. The total duration of your participation will involve the treatment period itself and then ongoing follow-up, which could last for several months or even years.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment combination that might be more effective than standard treatments alone for your specific type of lymphoma. However, like all medical treatments, there are potential risks, including side effects from the Romidepsin and CHOEP chemotherapy. These side effects can vary in severity. Your medical team will carefully explain all known risks before you make a decision. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

—
Italy

Common questions

What is Romidepsin?

Romidepsin is a drug being tested in this study. It's designed to work with standard chemotherapy to treat certain types of T-cell lymphoma.

What is CHOEP?

CHOEP is a common combination of chemotherapy drugs that doctors use to treat some types of lymphoma. It's a standard treatment.

Why is this study only for 'young patients'?

The study mentions 'young patients' in the title, which often refers to adults in a specific age range for cancer studies, typically under 60-65. However, the eligibility states 18 years to any age. Your doctor can clarify if this applies to you.

What is a 'stem cell transplant'?

A stem cell transplant is a medical procedure used to treat some cancers. It involves replacing damaged blood-forming cells with healthy ones, often after high-dose chemotherapy.

What does 'Phase I-II' study mean?

This means the study combines two early stages of research. Phase I aims to find the right and safest dose of the new drug, and Phase II then checks how well that dose works.