Study on Azacitidine, Roginolisib, and Golcadomide for Patients with Relapsed or Refractory Peripheral T-Cell Lymphomas

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What is this study about?

This clinical trial is focused on studying new treatments for a type of cancer called Peripheral T-Cell Lymphoma that has either returned after treatment or has not responded to previous treatments. The study will explore the effects of several medications, including Azacitidine, IOA-244 (also known as Roginolisib), and Golcadomide (also referred to by its code name CC-99282). These medications are being tested to see if they can improve outcomes for patients with this challenging condition.

The purpose of the study is to determine the safety and tolerability of these medications, as well as to identify the most effective doses. The study will be conducted in two phases. In the first phase, researchers will focus on finding the safest dose of the medications by gradually increasing the dose and monitoring for any side effects. In the second phase, the study will aim to identify which of these medications, or combinations of them, can significantly improve the condition of patients with relapsed or refractory Peripheral T-Cell Lymphoma.

Participants in the study will receive one or more of the study medications in the form of tablets or capsules, taken orally. The study will monitor participants over time to assess how well the medications are working and to check for any side effects. The ultimate goal is to find new and effective treatment options for patients with this type of lymphoma, improving their quality of life and potentially extending their survival.

1 beginning of the trial

Upon joining the trial, you will start by taking the study medication. This trial involves the use of several medications, including azacitidine, roginolisib, and golcadomide. These medications are administered orally in the form of tablets or capsules.

The trial is divided into two phases. In Phase 1, the focus is on determining the safety and tolerability of the medications. This involves gradually increasing the dose to find the maximum dose that can be tolerated without significant side effects.

2 medication administration

You will be required to take the medications as prescribed. The specific dosage and frequency will be provided by the study team. It is important to follow these instructions carefully to ensure the effectiveness and safety of the treatment.

The duration of medication administration will depend on the specific phase of the trial and your response to the treatment. Regular monitoring will be conducted to assess your progress and any potential side effects.

3 monitoring and assessments

Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the medication. This may include blood tests, imaging studies, and other evaluations as necessary.

These assessments are crucial for determining the effectiveness of the treatment and for making any necessary adjustments to your medication regimen.

4 phase 2 of the trial

In Phase 2, the goal is to identify drugs that significantly improve outcomes for patients with relapsed or refractory peripheral T-cell lymphomas. This phase will continue to monitor your response to the treatment and any side effects experienced.

Your participation in this phase will help determine the potential benefits of the medications for future patients with similar conditions.

5 completion of the trial

At the end of the trial, a final assessment will be conducted to evaluate your overall response to the treatment. This will include a review of your health status and any changes observed during the trial.

The information gathered from your participation will contribute to the overall understanding of the treatment’s effectiveness and safety.

Who Can Join the Study?

The person must be at least 18 years old.
The person must have a type of cancer called peripheral T-cell lymphoma that has come back or not responded to treatment.
The person must have a confirmed diagnosis of peripheral T-cell lymphoma according to specific medical guidelines.
The person must have a life expectancy of at least 3 months.
The person must be able to understand and sign a consent form before any study-related procedures.
The person must be willing and able to follow the study schedule and requirements.
The person must have adequate bone marrow function, which means:
- ANC (a type of white blood cell count) must be at least 1.5 x 10⁹/L, or 1 x 10⁹/L if related to lymphoma.
- Platelet count must be at least 75 x 10⁹/L, or 50 x 10⁹/L if related to lymphoma.
- Hemoglobin level must be at least 8 g/dL.
The person must have a performance status of 0 to 2, or 3 if it is related to lymphoma. This is a measure of how well the person can perform daily activities.
The person must have a fluorodeoxyglucose PET-scan showing at least one positive lesion, which is a way to see active cancer areas in the body.
The person must have at least one measurable tumor, either in a lymph node or outside of it.
The person must be covered by a social security system.
The person must understand and speak one of the official languages of the country where the study is conducted, unless a translator is allowed.
For women who can have children, they must have a negative pregnancy test before starting the study and agree to use effective birth control methods during the study and for a specified time after.
For men, they must agree to use a condom during the study and for a specified time after, and not donate sperm during this period.

Who Cannot Join the Study?

Patients with any other type of cancer that is not relapsed or refractory peripheral T-cell lymphomas cannot participate. Relapsed means the cancer has come back after treatment, and refractory means the cancer does not respond to treatment.
Patients who are pregnant or breastfeeding are not eligible to participate.
Patients with severe or uncontrolled medical conditions that could interfere with the study treatment are excluded. This means if you have a serious health issue that is not well-managed, you cannot join the study.
Patients who have had another investigational drug or treatment within a certain period before the study starts cannot participate. An investigational drug is a medication that is being tested and is not yet approved for general use.
Patients with known allergies to the study drug or its components are not eligible. This means if you have had an allergic reaction to the medication being tested or any of its ingredients, you cannot join the study.
Patients with a history of non-compliance with medical treatments or procedures are excluded. This means if you have not followed medical advice or treatment plans in the past, you cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cxleof Hjwtzanunuy Udodmshdagcfc Dp Ddmrf	Dijon	France
Cfgu Dd Nqnqp	Vandoeuvre Les Nancy	France
Capztt Hlpsirxxoka Rixbllnh Dyqfzgsybsvozv	Angers	France
Ivffovfa dw Cdkvraxlkfob Hptmcvlayps Uwgtxqdvqliam dq Sndox Ecknaut (yhmvvcn	Saint Priest En Jarez	France
Igtsoqpm Pzufdqwpeooylgd Ckwads Cakzcq	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.06.2025

Trial locations

Investigated drugs:

Roginolisib

Sub-study Treatment is a medication being tested in this clinical trial for people with a type of cancer called Peripheral T-Cell Lymphoma that has come back or hasn’t responded to previous treatments. The goal of this trial is to find out how safe and tolerable this treatment is when given in increasing amounts. Researchers want to determine the highest amount of the medication that patients can take without experiencing severe side effects. This will help them decide the best dose to use in future studies. The trial also aims to see if this treatment can improve the health outcomes for patients with this type of cancer.

Investigated diseases:

Peripheral T-cell lymphoma unspecified

Relapsed or Refractory Peripheral T-Cell Lymphomas – This is a type of cancer that originates in the T-cells, which are a part of the immune system. It occurs when these cells grow uncontrollably and form tumors in the lymphatic system. The disease is termed “relapsed” when it returns after treatment and “refractory” when it does not respond to treatment. As the disease progresses, it can spread to other parts of the body, including the blood, bone marrow, and other organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-514954-63-00

Protocol code:

PLATFORM

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Azacitidine, Roginolisib, and Golcadomide for Patients with Relapsed or Refractory Peripheral T-Cell Lymphomas

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?