Study on Loncastuximab Tesirine for Patients with Relapsed or Refractory Mantle Cell Lymphoma After Immunochemotherapy with Rituximab, Bendamustine, and Cytarabine

1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma (MCL), which is a rare form of non-Hodgkin’s lymphoma. The study is investigating the effectiveness of a treatment called loncastuximab tesirine, also known by its code name ADCT-402. This treatment is being tested in patients who have previously been treated with or are intolerant to a type of medication known as Bruton Tyrosine Kinase inhibitors (BTKi). The trial aims to see how well loncastuximab tesirine works when used after a short course of a combination of drugs called Rituximab, Bendamustine, and Cytarabine, collectively referred to as R-BAC.

Participants in the study will receive the treatment through an intravenous method, which means the medication is given directly into a vein. The study will follow the participants over a period to observe the effects of the treatment on their condition. The main goal is to assess how long patients can go without their disease getting worse after receiving the treatment. The study will also look at other outcomes, such as overall survival, which is the length of time patients live after starting the treatment, and the rate at which patients’ conditions improve or stabilize.

Throughout the study, researchers will monitor for any side effects or adverse events that may occur. This information will help determine the safety and effectiveness of loncastuximab tesirine as a treatment option for patients with relapsed or refractory Mantle Cell Lymphoma. The study is designed to provide valuable insights into whether this treatment can offer a new option for patients who have limited choices due to their previous treatments.

1 initial treatment phase

The initial treatment phase involves two courses of a combination therapy known as R-BAC. This includes the medications rituximab, bendamustine hydrochloride, and cytarabine. All medications are administered through an intravenous route.

The purpose of this phase is to prepare for the subsequent consolidation treatment. The specific dosage and frequency of administration will be determined by the healthcare provider based on individual patient needs.

2 consolidation treatment

Following the initial treatment phase, the consolidation treatment begins. This involves the administration of loncastuximab tesirine, also given intravenously.

The goal of this phase is to enhance the effectiveness of the initial treatment and to help maintain the response achieved. The duration and specific schedule of this treatment will be provided by the healthcare team.

3 monitoring and follow-up

After completing the consolidation treatment, regular monitoring and follow-up appointments are scheduled. These appointments are crucial for assessing the response to treatment and for early detection of any recurrence or progression of the disease.

During these visits, various assessments may be conducted, including imaging tests and blood work, to evaluate the patient’s condition and to ensure the treatment’s effectiveness.

Who Can Join the Study?

Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to the 2017 World Health Organization classification.
Must have a performance status of 2 or less on the ECOG/WHO scale, which measures how well a person can perform daily activities, unless the status is related to MCL.
Must have certain laboratory test results at screening, unless affected by lymphoma in the bone marrow:
- Absolute neutrophil count (ANC) greater than 1.0 x 10⁹/L.
- Platelet count of at least 75,000 per mm³.
- Creatinine clearance of at least 40 mL/min, which measures kidney function.
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels no more than 3 times the upper limit of normal (ULN), which are liver enzymes.
- Bilirubin level no more than 1.5 times the ULN, unless the increase is due to Gilbert’s syndrome or a non-liver-related cause.
Must understand and voluntarily sign an informed consent form approved by the National Ethic Committee before any study procedures begin.
Must be able to follow the study visit schedule and other study requirements.
Must have a life expectancy of at least 3 months.
Women who can have children must agree to use effective birth control if sexually active, from signing the consent form until at least 10 months after the last dose of the study drug. Men with female partners who can have children must also agree to use effective birth control if sexually active, from signing the consent form until at least 7 months after the last dose of the study drug.
Must be between 18 and 84 years old.
Must have relapsed or refractory disease after one to four previous treatments.
Must be either new to bendamustine treatment or have relapsed at least one year after the last cycle of a bendamustine-containing treatment.
Must have had previous treatment with Bruton Tyrosine Kinase inhibitors (BTKi) alone or in combination, and have relapsed or refractory disease, or have stopped BTKi treatment due to side effects and need treatment for active disease.
Previous treatment with any anti-CD19 agents, including CAR-T treatment, is allowed. If treated with anti-CD19, CD19 expression must be checked by histology or flow cytometry.
Patients treated with venetoclax are allowed.
Patients eligible for stem cell transplant are allowed.
Must have measurable disease in lymph nodes or outside of lymph nodes that is at least 1.5 cm in the longest diameter and measurable in two directions. Patients with only bone marrow involvement are eligible, but bone marrow aspiration and biopsy are required for all evaluations.

Who Cannot Join the Study?

Patients who have not been treated with Bruton Tyrosine Kinase inhibitors (BTKi) or are not intolerant to BTKi.
Patients who have not experienced a return or worsening of their Mantle Cell Lymphoma after previous treatment.
Patients who have not received salvage immunochemotherapy, specifically 2 courses of Rituximab-Bendamustine-Cytarabine (R-BAC).
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are part of a vulnerable population that is not selected for this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Aetjarn Oqswltyxlfe Ohqowzue Rfcsubp Vmrze Simqw Cgpmntal	Palermo	Italy
Aldbeny Okpcedwwhry Umvfnderpefce Chlqrxbelgga Dcjah Swuuys E Dgfaa Sjntfkg Dj Tgnbfd	Turin	Italy
Atqkjia Onpndexiakc Nvwcxmpdk Sk Acyvjxl E Bmlwos E C Arhpxn Aviruumaljg	Alexandria	Italy
Anbdrhv Uem Irnyn Df Rlfvsv Exisvw	Reggio Emilia	Italy
Ubposspbrp Dzmnz Scnbs Df Rigy Lj Sozzdjlj	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	21.03.2022

Trial locations

Investigated drugs:

Loncastuximab Tesirine is a medication being studied for its effectiveness in treating patients with Mantle Cell Lymphoma who have already been treated with or are intolerant to Bruton Tyrosine Kinase inhibitors. It is used as a consolidation therapy, which means it is given after initial treatment to help strengthen the response to the treatment and potentially improve outcomes.

Rituximab is a medication used in combination with other drugs as part of the initial treatment for Mantle Cell Lymphoma. It works by targeting specific cells in the immune system to help fight the cancer.

Bendamustine is a chemotherapy drug that is used alongside other medications to treat Mantle Cell Lymphoma. It helps to kill cancer cells and reduce the size of tumors.

Cytarabine is another chemotherapy medication used in combination with other drugs to treat Mantle Cell Lymphoma. It works by interfering with the growth of cancer cells, slowing down or stopping their spread.

Investigated diseases:

Mantle Cell Lymphoma – Mantle cell lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, a kind of white blood cell. It typically begins in the lymph nodes but can also affect other areas such as the spleen, bone marrow, and digestive tract. The disease is characterized by the overproduction of abnormal B-cells, which can lead to the enlargement of lymph nodes and other organs. As it progresses, it may cause symptoms like fatigue, fever, night sweats, and weight loss. The disease can vary in its rate of progression, with some cases advancing slowly while others may progress more rapidly.

Trial ID:

2024-511633-35-00

Protocol code:

FIL_COLUMN

NCT ID:

NCT05249959

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Loncastuximab Tesirine for Patients with Relapsed or Refractory Mantle Cell Lymphoma After Immunochemotherapy with Rituximab, Bendamustine, and Cytarabine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?