Centre Hospitalier Lyon Sud
Pierre Benite, France
Not recruitingAngioimmunoblastic T-cell lymphoma refractory
Study on the Effectiveness and Safety of Azacitidine, Gemcitabine, and Bendamustine Hydrochloride for Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a type of cancer called Angioimmunoblastic T-cell Lymphoma, which is a rare form of non-Hodgkin lymphoma. The study is investigating the effectiveness and safety of a medication called Azacitidine, which is taken orally in the form of a tablet. The trial compares this treatment to other therapies chosen by the doctors involved in the study. The purpose of the study is to see how well patients do without their disease getting worse.
Participants in the study will receive either Azacitidine or another treatment selected by their doctor. The study will monitor the patients over a period to see how the disease responds to the treatment. The trial will also look at how long patients live overall and how their quality of life is affected by the treatment. The study aims to provide more information on the best treatment options for patients with this type of lymphoma.
Other medications involved in the study include Gemcitabine and Bendamustine Hydrochloride, which are given through infusion, meaning they are administered directly into the bloodstream. The study will help determine if Azacitidine is a better option compared to these and other treatments. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important data on the treatment's effects.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
14 criteria
- Patient is 18 years or older at the time of signing the informed consent form.
- Female patients who can have children must have two negative pregnancy tests before starting the study treatment and agree to ongoing pregnancy testing during the study. They must use highly effective birth control methods or practice true abstinence during the study and for up to 6 months after the last study drug administration. They must also agree not to breastfeed during the study and for at least 6 months after the last study drug administration.
- Male patients must agree to use highly effective birth control methods or practice true abstinence during the study and for 6 months after the last study drug administration. They must also agree not to donate semen or sperm during the study and for 1 year after the study ends.
- For patients in EU countries, they must be covered by a social security system.
- Patient must understand and voluntarily sign an informed consent form before any study-specific assessments or procedures are conducted.
- Patient is willing and able to follow the study visit schedule and other study requirements.
- Patient has been diagnosed with peripheral T cell lymphoma with T-follicular helper phenotype, confirmed by a biopsy. This includes Angioimmunoblastic T cell lymphoma, Follicular T cell lymphoma, or Nodal peripheral T-cell lymphoma with TFH phenotype. The diagnosis must show at least two specific markers (CD10, CXCL13, PD1, ICOS, BCL6) on the tumor cells.
- Patient has an ECOG performance status of 0 to 3, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
- Patient has relapsed or refractory Angioimmunoblastic T cell lymphoma after at least one line of systemic therapy.
- Patient meets the following laboratory criteria:
- Absolute Neutrophil Count (ANC) of at least 1.5 x 109/L (or at least 1 x 109/L if the bone marrow is involved by lymphoma).
- Platelet count of at least 75 x 109/L (or at least 50 x 109/L if the bone marrow is involved by lymphoma).
- Hemoglobin level of at least 8 g/dL.
- Patient has an anticipated life expectancy of at least 3 months.
- Patient has at least one measurable lesion on a CT scan that is greater than 1.5 cm in the longest diameter for nodal lesions and greater than 1.0 cm in the longest diameter for extranodal lesions. The lesion must be measurable in two perpendicular dimensions. Patients with only skin disease will be excluded.
Who cannot join the trial?
10 criteria
- Patients with any other type of cancer that is not the specific type being studied.
- Patients who have had a different cancer in the past, unless it was successfully treated and has not come back for a certain period.
- Patients who have a serious infection that is not under control.
- Patients who are pregnant or breastfeeding.
- Patients who have a known allergy to the study medication or any of its ingredients.
- Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
- Patients who are currently participating in another clinical trial.
- Patients who have had a major surgery within a certain time frame before the study starts.
- Patients who have a history of certain heart conditions.
- Patients who have a history of certain lung conditions.
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Verified sites
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Verified Verified Hopital Beaujon
Clichy, France
Trial locations
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Investigated drugs
Oral Azacitidine (CC-486) is a medication being tested in this clinical trial. It is designed to help treat a type of cancer called Angioimmunoblastic T cell Lymphoma, which is a rare form of non-Hodgkin lymphoma. This medication is taken by mouth and works by interfering with the growth of cancer cells, potentially slowing down or stopping their spread. The trial aims to see if this medication can help patients live longer without their disease getting worse.
What is already known about the treatment
Oral Azacitidine (CC-486) – This medication is administered orally, meaning it is taken by mouth in the form of a pill. It is currently being studied in clinical trials for its effectiveness and safety in treating a type of cancer called Relapsed or Refractory Angioimmunoblastic T cell Lymphoma. The main goal of using this medication is to help patients live longer without the disease getting worse. At the molecular level, Azacitidine works by interfering with the DNA in cancer cells, which can stop them from growing and dividing. It is classified as a type of chemotherapy drug.
Investigated diseases
Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma – This is a type of non-Hodgkin lymphoma that affects T-cells, which are part of the immune system. It is characterized by the abnormal growth of lymphocytes, leading to enlarged lymph nodes, fever, weight loss, and skin rashes. The disease can progress by spreading to other lymph nodes and organs, causing further symptoms such as fatigue and night sweats. Over time, the lymphoma may become resistant to treatment, making it more challenging to manage. The progression involves the continued proliferation of malignant T-cells, which can disrupt normal immune function. As the disease advances, it can lead to more severe systemic symptoms and complications.
Ongoing clinical trials in Angioimmunoblastic T-cell lymphoma refractory
Other trials in this disease – keep exploring while you decide
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Anaplastic large cell lymphoma T- and null-cell types+2
Not recruitingInvestigational
Study of Romidepsin and Drug Combination for Young Patients with Peripheral T-Cell Lymphomas Before Stem Cell Transplantation
Investigational
- Disease:Anaplastic large cell lymphoma T- and null-cell typesPeripheral T-cell lymphoma unspecified+1
- Substances:Romidepsin
Countries:
Italy
Italy- Participants:18–64 years
- Substances:Romidepsin
- Sponsor:Fondazione Italiana Linfomi Ets
Trial detailsLast updated 2 Oct 2026
sourced from the EU Clinical Trials Register and site verification
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