Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Peripheral T-cell Lymphoma (PTCL), which is a cancer of the immune system’s T-cells. The study is specifically for patients whose cancer has returned or has not responded to previous treatments, known as relapsed/refractory Peripheral T-cell Lymphoma (R/R PTCL). The trial will test the safety and effectiveness of a new treatment combination. This includes a medication called Tolinapant, which is taken as a capsule, and a combination of two substances, Decitabine and Cedazuridine, which are taken as a tablet.

The purpose of the study is to find out how safe these treatments are and how well they work in treating R/R PTCL. The study will be conducted in two phases. In the first phase, researchers will determine the safest dose of Tolinapant when used with Decitabine/Cedazuridine. In the second phase, they will evaluate how effective the treatment is in reducing the cancer. Participants will receive either the combination of Tolinapant with Decitabine/Cedazuridine or Decitabine/Cedazuridine alone. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, participants will take the medications orally, meaning by mouth. The study will monitor the participants’ health and any side effects they may experience. The trial aims to provide valuable information on whether this combination of treatments can help manage R/R PTCL more effectively. The study is expected to continue until 2026, with the goal of improving treatment options for patients with this challenging form of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

A pregnancy test is required for women of childbearing potential. Both men and women must agree to use effective birth control methods during the study and for a specified period after the study ends.

2 treatment phase 1

In the first phase, the patient receives a combination of tolinapant and oral decitabine/cedazuridine. These medications are taken by mouth in the form of tablets and capsules.

The purpose of this phase is to assess the safety of the treatment and determine the appropriate dosage for the next phase.

3 treatment phase 2

In the second phase, the patient continues to receive the treatment to evaluate its effectiveness. The focus is on measuring the response to the treatment using imaging techniques.

The patient’s health and response to the treatment are closely monitored throughout this phase.

4 regular monitoring

Throughout the study, regular check-ups and tests are conducted to monitor the patient’s health and any side effects from the treatment.

These assessments help ensure the patient’s safety and provide data on the treatment’s impact.

5 end of study

At the end of the study, a final assessment is conducted to evaluate the overall response to the treatment.

The patient may be asked to continue follow-up visits to monitor long-term effects and gather additional data.

Who Can Join the Study?

Must be able to understand and follow the study rules and procedures, and agree to participate by signing a consent form.
Women who can have children must not be pregnant or breastfeeding. They must have a negative pregnancy test before starting the study and agree to use a very effective form of birth control during the study and for 6 months after the last treatment. Men with partners who can have children must use a condom and ensure their partners use a very effective form of birth control during the study and for at least 3 months after the last treatment.
Must be 18 years of age or older.
Must have a life expectancy of more than 12 weeks.
Must have a confirmed diagnosis of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) according to specific medical classifications.
Must show evidence of disease progression and have received at least two previous treatments for their condition.
Must have measurable disease as shown by a specific type of imaging test (CT scan).
If the disease is CD30-positive, must have received, be ineligible for, or unable to tolerate a specific treatment called brentuximab vedotin, if it is available.
Must have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
Must have acceptable organ function as shown by specific laboratory tests, including liver and kidney function tests, and blood cell counts.

Who Cannot Join the Study?

Patients who do not have relapsed/refractory peripheral T-cell lymphoma (R/R PTCL) cannot participate. This means the study is only for those whose specific type of lymphoma has returned or did not respond to treatment.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are unable to provide informed consent cannot participate. This means they must understand the study and agree to take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Centre Henri Becquerel	Rouen	France
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Semmelweis University	Budapest	Hungary
Hopitaux Universitaires Pitie Salpetriere	Paris	France
University Of Debrecen	Debrecen	Hungary
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Unita Sanitaria Locale Della Romagna	Ravenna	Italy
Cymrnz Lede Bsokem	Lyon	France
Ilywhqsd Rvbizzhvy Pzn Lp Svixzt Dag Tkczvi Dxlg Aiypsuq Iqzp Snqtjs	Meldola	Italy
Czobgl Hvywgqdyysy Rulktjfa Ufikoskttgfjf De Tpbwt	Tours	France
Abibmnj Owkfrmlwphw Usrqwndcwcwxg Ctbhcrooimog Dzols Sqdhkc E Dkpcf Srymxzu Dl Tmjxqn	Turin	Italy
Ariirqx Uenhk Snpuifhsy Ldptdh Dl Bilbkvd	Bologna	Italy
Udmbfybidrsyks Clswtkk Kjislqiyg	Gdansk	Poland
Hzztphdn Uavrjgeizpomt Mmnzcrk Dg Vwxeeievnj	Santander	Spain
Ikerewrp Cudxfr Degyhiytkogogvrwt	L'hospitalet De Llobregat	Spain
Ijucsnwn Przjucpbnlppcgs Cnqvix Ctxqry	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.01.2023
Hungary	Not recruiting	31.01.2023
Italy	Not recruiting	31.01.2023
Poland	Not recruiting	31.01.2023
Spain	Not recruiting	31.01.2023

Trial locations

Investigated drugs:

Tolinapant is a medication being studied for its potential to help treat a type of cancer called peripheral T-cell lymphoma, which is a cancer of the immune system. In this trial, researchers are looking at how safe it is to use and how it works in the body when combined with another treatment. They are also trying to find the best dose to use in future studies.

Decitabine/Cedazuridine is a combination of two medications taken by mouth. Decitabine is a type of drug that can help stop cancer cells from growing and multiplying. Cedazuridine is included to help decitabine work better by preventing it from being broken down too quickly in the body. This combination is being tested to see how effective it is in treating peripheral T-cell lymphoma, especially in patients whose cancer has returned or has not responded to previous treatments.

Peripheral T-cell lymphoma – Peripheral T-cell lymphoma is a type of cancer that originates in the T-cells, which are a part of the immune system. It is characterized by the abnormal growth of T-cells, which can spread to lymph nodes and other organs. The disease often begins with symptoms such as swollen lymph nodes, fever, and weight loss. As it progresses, it can affect the skin, liver, and bone marrow. The progression of the disease can vary, with some cases advancing rapidly while others develop more slowly. The exact cause of peripheral T-cell lymphoma is not well understood, but it involves genetic mutations in the T-cells.

Trial ID:

2022-500391-62-00

Protocol code:

ASTX660-03

NCT ID:

NCT05403450

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?