Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called T-cell lymphoma, which includes specific subtypes such as Cutaneous T-cell lymphoma and Mycosis fungoides. These are advanced forms of cancer that affect the skin and other parts of the body. The treatment being tested in this study is a medication called Lacutamab, also known by its code name IPH4102. Lacutamab is a type of protein treatment known as a monoclonal antibody, which is designed to target and attack cancer cells. The study will explore the effects of Lacutamab when used alone or in combination with chemotherapy.

The purpose of this study is to evaluate how well patients respond to the treatment. Participants will receive Lacutamab through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants over a period to see how their cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Lacutamab. The study will also assess the safety of the treatment and any side effects that may occur.

Throughout the study, researchers will collect information on how the treatment affects the participants’ quality of life and overall health. This includes monitoring any changes in symptoms and conducting regular health checks. The study aims to provide valuable insights into the effectiveness of Lacutamab for treating advanced T-cell lymphoma and to determine if it can be a beneficial treatment option for patients with this type of cancer.

1 joining the study

Upon joining the study, the patient will undergo a screening process to confirm eligibility. This includes a review of medical history and a physical examination.

A skin biopsy may be required to assess the condition of the skin lesions.

2 treatment initiation

The patient will begin treatment with Lacutamab, administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

A minimum wash-out period of 3 weeks is required between the last dose of any prior systemic therapy and the first dose of Lacutamab.

3 treatment phase

During the treatment phase, the patient will receive regular infusions of Lacutamab. The duration and frequency of these infusions will be specified in the study protocol.

The patient’s response to the treatment will be monitored through regular assessments, including blood tests and imaging studies.

4 safety and efficacy assessments

The study will evaluate the objective response rate (ORR), which measures the proportion of patients with a complete or partial response to the treatment.

Safety assessments will include monitoring for adverse events, changes in laboratory evaluations, and vital signs.

5 quality of life assessments

The patient’s quality of life will be assessed using a questionnaire and a visual analog scale (VAS) for pruritus.

These assessments aim to understand the impact of the treatment on the patient’s daily life and well-being.

6 end of treatment

The treatment phase will conclude as per the study protocol, or if the patient experiences disease progression or unacceptable side effects.

Follow-up assessments may be conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

Patients with Sézary Syndrome (SS) must have a type of cancer that has come back or not responded to treatment, specifically stage IVA or IVB, and have tried at least two different treatments before.
Patients with Mycosis Fungoides (MF) must have a type of cancer that has come back or not responded to treatment, specifically stage IB, IIA, IIB, III, or IV, and have tried at least two different treatments before.
Patients must be able to have at least one skin sample taken for testing at the start of the study.
Patients must be at least 18 years old.
Patients must have a performance status of 2 or less, which means they should be able to carry out daily activities with some help.
Patients must wait at least 3 weeks after their last treatment before starting the study treatment.
Patients should have recovered from any side effects of previous treatments, except for hair loss, to a mild level.
Patients must have certain blood test results within normal ranges, such as hemoglobin, neutrophil count, and platelets.
Patients must have certain liver and kidney function test results within normal ranges.
Women who can become pregnant must have a negative pregnancy test before starting the study.
Women who can become pregnant and all men must agree to use birth control during the study and for 9 months after the last dose of the study drug.
Patients must sign a consent form agreeing to participate in the study.
Patients with SS must have had treatment with a specific drug called mogamulizumab before.
Patients with SS must have a certain level of cancer cells in their blood, confirmed by a test called flow cytometry.
For MF patients in a specific group, their skin must show a certain protein called KIR3DL2 in at least one skin lesion, confirmed by a test called IHC.

Who Cannot Join the Study?

Patients with other types of cancer that are not the specific T-Cell Lymphomas being studied.
Patients who have not experienced a return or worsening of their T-Cell Lymphoma after treatment.
Patients with serious infections that are not controlled or treated.
Patients with significant heart problems that could affect their health during the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently.
Patients with a history of severe allergic reactions to similar treatments.
Patients with certain autoimmune diseases, which are conditions where the immune system attacks the body.
Patients with liver or kidney problems that are severe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Institut Jules Bordet	Anderlecht	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Avmuqrl Olfiyzdydzj Ubbtlzycgfhji Cobyckjwabin Dipxq Sgfgsq E Dkyai Suvnqiu Da Twfijl	Turin	Italy
Uookoyjxurfjpvinnhhjy Mwdxntqu Abg	Munster	Germany
Nzwpxwqo Izxlhefp Oddyyxxuq Iul Mxebw Smthfgeazzlkcnvfgyhkdtisnqoc Iaojezwo Bbcjomnv	Cracow	Poland
Gteinb Ujftjwrsds Feieehdqa	Frankfurt	Germany
Awnukem Upvaw Slnlrtcmr Lyterk Ds Bmkdyin	Bologna	Italy
Ujrhrvrarevhmi Cqofqpv Knmkydvje	Gdansk	Poland
Iwwgikcx Psmxktuavmqzgyh Cmnlyc Clmuzv	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	22.05.2019
France	Not recruiting	22.05.2019
Germany	Not recruiting	22.05.2019
Italy	Not recruiting	22.05.2019
Poland	Not recruiting	22.05.2019
Spain	Not recruiting	22.05.2019

Trial locations

Investigated drugs:

Lacutamab

IPH4102 is a medication being studied for its potential to treat advanced T-cell lymphoma. It is designed to target a specific protein on the surface of cancer cells, which may help the immune system recognize and attack these cells more effectively. This medication is being tested alone to see how well it works in shrinking or controlling the cancer.

Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is combined with IPH4102 to evaluate if the combination is more effective than using IPH4102 alone. Chemotherapy works by stopping the growth of cancer cells, which can help reduce the size of tumors and slow the progression of the disease.

Cutaneous T-Cell Lymphoma (CTCL) – This is a type of cancer that begins in the T-cells, which are part of the immune system, and primarily affects the skin. It often presents as patches, plaques, or tumors on the skin and can cause itching and redness. Over time, the disease may progress to involve the lymph nodes, blood, and internal organs. CTCL includes various subtypes, such as Mycosis Fungoides and Sézary Syndrome, each with distinct characteristics. Mycosis Fungoides typically starts with skin lesions that may evolve into tumors, while Sézary Syndrome is characterized by widespread skin involvement and the presence of malignant T-cells in the blood. The progression of CTCL can vary significantly among individuals, with some experiencing slow progression and others more rapid changes.

Trial ID:

2023-507777-18-00

Protocol code:

IPH4102-201

NCT ID:

NCT03902184

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma

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