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Study of Lacutamab, Gemcitabine, and Oxaliplatin 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 rare and aggressive form of non-Hodgkin lymphoma. The study is specifically for patients whose cancer has returned or has not responded to previous treatments. The trial will test a new treatment approach using a medication called Lacutamab, also known by its code name IPH4102, in combination with two chemotherapy drugs, Gemcitabine and Oxaliplatin, collectively referred to as GemOx. The purpose of the study is to evaluate how effective Lacutamab is when used with GemOx compared to using GemOx alone.

Participants in the study will be randomly assigned to receive either the combination of Lacutamab with GemOx or GemOx alone. Lacutamab is a type of protein-based treatment known as a monoclonal antibody, which is designed to target specific cancer cells. Gemcitabine and Oxaliplatin are chemotherapy drugs that work by stopping the growth of cancer cells. The treatment will be given through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will monitor the participants over a period to see how the cancer responds to the treatment and to assess the safety and potential side effects of the medications.

The trial aims to provide valuable information on whether adding Lacutamab to the standard GemOx treatment can improve outcomes for patients with relapsed or refractory Peripheral T-Cell Lymphoma. This study is important for understanding new ways to treat this challenging disease and may help in developing more effective treatment options in the future.

1 randomization

Upon joining the study, the patient is randomly assigned to one of two groups. One group receives a combination of lacutamab with gemcitabine and oxaliplatin (GemOx), while the other group receives GemOx alone.

Randomization ensures that each patient has an equal chance of being assigned to either treatment group.

2 treatment administration

The patient receives the assigned treatment intravenously. This involves the administration of medications directly into a vein.

For those in the lacutamab with GemOx group, lacutamab is administered alongside gemcitabine and oxaliplatin. The specific dosage and frequency are determined by the study protocol.

3 treatment cycle

The treatment is given in cycles. Each cycle consists of a period of treatment followed by a period of rest to allow the body to recover.

The duration of each cycle and the number of cycles are specified in the study protocol.

4 monitoring and assessments

Throughout the study, the patient’s health and response to treatment are closely monitored. This includes regular medical assessments and imaging tests.

The purpose of these assessments is to evaluate the effectiveness of the treatment and to monitor for any side effects.

5 maintenance phase

For patients receiving lacutamab, a maintenance phase follows the initial treatment cycles. During this phase, lacutamab is administered to help maintain the response to treatment.

The frequency and duration of the maintenance phase are determined by the study protocol.

6 end of study participation

The patient’s participation in the study concludes after completing the treatment cycles and maintenance phase, or if certain criteria are met, such as disease progression or the need for additional unplanned treatments.

At the end of the study, final assessments are conducted to gather comprehensive data on the patient’s response to the treatment.

Who Can Join the Study?

  • The patient must have a type of cancer called Peripheral T-Cell Lymphoma (PTCL) that has come back or not responded to treatment.
  • The patient’s cancer cells must show a specific marker called KIR3DL2 in at least 1% of the cells, confirmed by a special test.
  • The patient must be able to perform daily activities with an ECOG performance status of 0 to 3 before starting any pre-treatment, and 0 to 2 before being randomly assigned to a treatment group. This is a scale that measures how well a patient can carry out daily activities.
  • The patient should have a life expectancy of at least 3 months.
  • Women who can have children must agree to use a highly effective birth control method from the start of the study, during any breaks in treatment, and for 9 months after the last treatment. They must also have a negative pregnancy test before starting the study.
  • Male patients and their female partners who can have children must agree to use two reliable forms of birth control (a condom for males and a hormonal method for partners) from the start of the study, during any breaks in treatment, and for 9 months after the last treatment.
  • The patient must be covered by a social security system in France.
  • The patient must understand and speak one of the official languages of the country where the study is conducted.
  • The patient must have a confirmed diagnosis of PTCL based on a biopsy, which is a procedure to remove a small piece of tissue for testing. The types of PTCL include PTCL-NOS, PTCL-TFH, ALCL, ATL, HSTL, EATL, MEITL, NKT, and ANKL.
  • For patients with ALCL (a type of PTCL), they must have been previously treated with a drug called brentuximab vedotin.
  • The patient must have had at least one previous treatment for PTCL that involved chemotherapy, with no required waiting period after the last treatment.
  • The patient can have had a maximum of two previous treatments, including a procedure called autologous stem cell transplantation (ASCT), which is a treatment that uses the patient’s own stem cells.
  • The patient must have a tumor that can be measured in two dimensions, with at least one tumor or lymph node that is 1.5 cm or larger, as seen on a CT scan, which is an imaging test.
  • The patient must sign a written consent form to be screened for the KIR3DL2 marker.
  • The patient must sign a written consent form to participate in the study.
  • The patient must be 18 years or older, with no upper age limit.

Who Cannot Join the Study?

  • Patients who have not experienced a return or worsening of their condition after previous treatment.
  • Patients who do not have a type of cancer called Peripheral T-Cell Lymphoma.
  • Patients who do not have a specific protein called KIR3DL2 on their cancer cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to receive the specific treatment plan outlined in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Grand Hopital De Charleroi Charleroi Belgium
CHR Verviers Verviers Belgium
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier D Avignon Avignon France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Universitaire d’Orléans Orléans France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Le Mans Le Mans France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
CHC MontLegia Liege Belgium
Centre Hospitalier De Perigueux Perigueux France
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Centre Hospitalier Bretagne Atlantique Vannes France
Grand Hopital De L Est Francilien Meaux France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Universitaire De Rennes Rennes France
CHU Helora La Louviere Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Alexandra Lepeve Dunkirk France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Cspqofsiv Uackbdmxuabwgz Skuqmxcqo Woluwe-Saint-Lambert Belgium
Cjttto Lhcm Baryji Lyon France
Ccjluf Hhaukmbbypn Umovhksxpkamk Rwdai Reims France
Hzolicax Unmpbvlcnjrhn Mumpjbc Dc Vknpkgrief Santander Spain
Ckh dpgvdbumgamxnq Epagny Metz Tessy France
Cmymvn Htlxicbgtoz Ew Uwhtkyxlesceb Do Lblkges Limoges France
Cbltdb Hczzpguyazw Uassdjedwhlhv Da Dlqkh Dijon France
Cpuu Di Npgeg Vandoeuvre Les Nancy France
Usbhtcardf Ov Arnunkz Edegem Belgium
Mepqmtpfljyikdhsbzbvcegixb Hddlojlewiigydgz Halle (Saale) Germany
Ckfyuh Hbirodsrkdj Rlrhycik Dlmfwtzavfxzhd Angers France
Igaxxuah dj Cjkrnfvaqtym Htdctgcatan Ufnkswsusotlr dc Sjzhz Ejcvlfz (myixnea Saint Priest En Jarez France
Hujmpzfd Vcpw dxfvuooz Barcelona Spain
Hmcgzoay Udjalehabvfwze Swqxtylrmj &xwkxjf Hkoywue ds Hwotikasonw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
07.12.2021
France France
Not recruiting
07.12.2021
Germany Germany
Not recruiting
07.12.2021
Spain Spain
Not recruiting
07.12.2021

Trial locations

Investigated drugs:

Lacutamab is an investigational medication being studied for its potential to treat certain types of T-cell lymphoma. It is being evaluated for its ability to help control the disease in patients who have not responded to previous treatments or whose disease has returned. In this trial, Lacutamab is used in combination with other cancer treatments to see if it can improve outcomes for patients.

Gemcitabine is a chemotherapy medication used to treat various types of cancer, including lymphoma. It works by interfering with the growth of cancer cells, slowing or stopping their spread in the body. In this study, Gemcitabine is used as part of a combination therapy to treat patients with relapsed or refractory T-cell lymphoma.

Oxaliplatin is another chemotherapy drug that is used to treat cancer. It is often combined with other medications to enhance its effectiveness. Oxaliplatin works by damaging the DNA of cancer cells, which can lead to their death. In this clinical trial, Oxaliplatin is used alongside Gemcitabine to treat patients with certain types of T-cell lymphoma.

Investigated diseases:

Peripheral T-cell Lymphoma – Peripheral T-cell lymphoma is a group of aggressive lymphomas that originate from mature T-cells. It is characterized by the uncontrolled growth of T-cells, which are a type of white blood cell. The disease often presents with symptoms such as swollen lymph nodes, fever, and weight loss. It can affect various parts of the body, including the lymph nodes, liver, and spleen. The progression of the disease can vary, with some subtypes being more aggressive than others. Treatment typically involves chemotherapy, but the disease can be challenging to manage due to its aggressive nature.

Trial ID:
2024-513252-15-00
Protocol code:
KILT
NCT ID:
NCT04984837
Trial Phase:
Therapeutic exploratory (Phase II)

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