Study on the Effectiveness and Safety of Azacitidine, Gemcitabine, and Bendamustine Hydrochloride for Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma

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What is this study about?

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.

1 beginning of the trial

Upon joining the study, the patient will start by taking part in an initial assessment. This includes a review of medical history and a physical examination to ensure eligibility for the trial.

The patient will be informed about the trial procedures, potential risks, and benefits. Consent will be obtained before proceeding.

2 treatment assignment

The patient will be randomly assigned to receive either oral azacitidine or another treatment chosen by the investigator. This is to compare the effectiveness and safety of the treatments.

The patient will be informed about the specific treatment they will receive, including the method of administration and any necessary precautions.

3 treatment administration

If assigned to oral azacitidine, the patient will take the medication by mouth. The dosage and frequency will be determined by the study protocol and communicated to the patient.

The duration of treatment will depend on the patient’s response and the study’s guidelines. Regular monitoring will occur to assess the patient’s health and any side effects.

4 regular monitoring

Throughout the trial, the patient will attend scheduled visits for health assessments. These may include blood tests, imaging studies, and other evaluations to monitor the disease and treatment effects.

The patient will be required to report any side effects or changes in health to the study team promptly.

5 end of treatment

Once the treatment phase is completed, the patient will undergo a final assessment to evaluate the overall response to the treatment.

The patient will receive guidance on any follow-up care or additional treatments that may be necessary after the trial concludes.

6 follow-up period

After the treatment ends, the patient will enter a follow-up period. This involves periodic check-ins to monitor long-term health outcomes and any delayed side effects.

The patient will be informed about the schedule and nature of these follow-up visits.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.11.2018

Trial locations

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.

Investigated diseases:

Angioimmunoblastic T-cell lymphoma refractory

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.

Trial ID:

2024-519336-16-00

NCT ID:

NCT03593018

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effectiveness and Safety of Azacitidine, Gemcitabine, and Bendamustine Hydrochloride for Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?