Study on the Safety and Effectiveness of LIS1 for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

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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 rare and aggressive form of non-Hodgkin lymphoma affecting the T-cells, a type of white blood cell. The study is testing a new treatment called LIS1, which is a glyco-humanized polyclonal antibody. This means it is a specially designed protein that targets and binds to specific cells in the body, in this case, the tumoral T-cells involved in PTCL. The treatment is administered as a concentrate for solution for infusion, meaning it is given directly into the bloodstream through an intravenous infusion.

The purpose of the study is to evaluate the safety and effectiveness of LIS1 in patients whose PTCL has returned or has not responded to previous treatments. The study is divided into two parts. In the first part, the focus is on determining the safest dose of LIS1 by gradually increasing the dose given to participants. This helps identify the maximum dose that can be tolerated without causing severe side effects. In the second part, the study will assess how well LIS1 works in treating PTCL by observing its effects on the cancer.

Participants in the study will receive LIS1 and will be monitored closely for any side effects and changes in their condition. The study aims to find out if LIS1 can effectively reduce the size of the tumors or slow down the progression of the disease. This research is important for developing new treatment options for patients with relapsed or refractory Peripheral T-cell Lymphoma.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide signed, written informed consent to participate.

The patient must meet specific health criteria, including a performance status that allows for daily activities and a life expectancy of more than three months.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility, which includes blood tests and imaging to measure the disease.

A bone marrow aspirate or biopsy may be required to provide a sample for central review.

3 treatment phase 1: dose escalation

The patient will receive the medication LIS1 through an intravenous infusion. The dosage will be gradually increased to determine the maximum tolerated dose.

Each treatment cycle lasts 28 days, during which the patient will be monitored for any side effects or adverse reactions.

4 treatment phase 2: dose expansion

Once the appropriate dose is identified, the patient will continue to receive LIS1 at this dose to evaluate its effectiveness against the disease.

The patient’s response to the treatment will be assessed using imaging and other clinical evaluations.

5 monitoring and follow-up

Throughout the trial, the patient will have regular check-ups to monitor health status, including blood tests and physical examinations.

The patient will be observed for any changes in the disease and any side effects from the treatment.

6 end of trial

The trial is expected to conclude by August 2027. At the end of the trial, the patient’s overall response to the treatment will be evaluated.

The patient will receive guidance on any further treatment or follow-up care needed after the trial.

Who Can Join the Study?

Provide signed, written informed consent, which means you agree to participate in the study after understanding all the details.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates you are fully active or have some symptoms but can still carry out light work.
Have a life expectancy of more than 3 months.
Have adequate blood and organ function, including:
- Hemoglobin level of at least 8.0 g/dL (blood transfusion is allowed).
- Absolute neutrophil count (ANC) of at least 1000 cells/mm³ (without support from growth factors within 7 days of measurement).
- Platelet count of at least 50,000 cells/mm³ (without support from growth factors or transfusion within 7 days of measurement).
- Creatinine clearance of at least 30 mL/min, which measures kidney function.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 3 times the upper limit of normal, which are liver enzymes.
- Serum total bilirubin less than 2 times the upper limit of normal, or less than 3 times for those with Gilbert’s Syndrome, which is a liver condition.
Be able to understand and sign an informed consent form.
Use adequate contraception during the study and for 6 months after completing therapy.
Be male or female and at least 18 years old at the time of giving consent.
For Part 1: Have a confirmed diagnosis of certain types of Peripheral T cells lymphoma (PTCL), which is a type of blood cancer, based on specific classifications.
Have received one or more appropriate treatments for the current disease, including specific types of chemotherapy. If you have Anaplastic Large Cell Lymphoma (ALCL), you must have received a specific drug called brentuximab vedotin or be unable to receive it due to allergy or intolerance.
Have experienced disease progression during or after the most recent therapy or have a disease that does not respond to treatment.
Have a measurable lesion, which is a tumor that can be measured by imaging tests. The longest diameter should be at least 1.5 cm for nodal lesions and more than 1 cm for extra-nodal lesions.
Have recovered from any side effects of previous treatments to a level that is less than Grade 1 or back to your normal state. You must not have had major surgery, chemotherapy, radiation, or biologic therapy within 2 weeks before starting the study treatment. Some exceptions may apply if the side effects do not pose a risk to you.
Have either unstained tissues or stained slides and a pathology report available for central review. If these are not available, a fresh tumor tissue sample is required.
Be able to provide a bone marrow sample no older than 3 months at screening and agree to provide another sample after treatment if needed to confirm response.

Who Cannot Join the Study?

Patients who have a different type of cancer than Peripheral T cells lymphoma (PTCL) cannot participate. PTCL is a type of cancer that affects certain white blood cells called T cells.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the specific health and safety requirements set by the study cannot participate. These requirements ensure the safety of participants.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Aqxvnxx Uskdb Syzdubxpb Llpuix Db Bcgxrza	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2024
Italy	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Anti-T Lymphocyte Immunoglobulin For Human Use, Pig

LIS1 is a glyco-humanized polyclonal antibody designed to target and attack tumoral T cells. It is being studied for its potential to treat patients with relapsed or refractory peripheral T cell lymphoma (PTCL). The trial aims to evaluate the safety and effectiveness of LIS1, determining the best dose to use in future studies.

Peripheral T-cell Lymphoma (PTCL) – Peripheral T-cell lymphoma is a group of aggressive lymphomas that originate from mature T-cells. It typically presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease can affect various parts of the body, including the lymph nodes, liver, spleen, and skin. PTCL progresses rapidly and can spread to other organs if not managed. The exact cause of PTCL is not well understood, but it involves the abnormal growth of T-cells. It is considered a rare type of non-Hodgkin lymphoma.

Trial ID:

2023-509648-88-00

Protocol code:

XT 23-10

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of LIS1 for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

What is this study about?

Who Can Join the Study?

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