Study Comparing Loncastuximab Tesirine and Rituximab with Standard Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating the effectiveness of a new treatment combination. The treatment involves a medication called Loncastuximab Tesirine, also known by its code name ADCT-402, combined with another medication called Rituximab. These medications are compared to standard immunochemotherapy, which is a treatment that uses the body’s immune system to fight cancer along with chemotherapy drugs.

The purpose of the study is to evaluate how well the combination of Loncastuximab Tesirine and Rituximab works compared to the usual treatment for patients whose DLBCL has returned after treatment or has not responded to previous treatments. The study will involve participants receiving these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over a period of time, with regular monitoring to assess the progress and any effects of the treatment.

Participants in the study will be randomly assigned to receive either the new treatment combination or the standard treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study aims to provide valuable information on whether the new treatment combination can improve outcomes for patients with relapsed or refractory DLBCL.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure adequate organ function and measurable disease.

2 randomization

Participants are randomly assigned to one of two groups: one receiving the combination of loncastuximab tesirine and rituximab, and the other receiving standard immunochemotherapy.

3 treatment administration

For those in the experimental group, loncastuximab tesirine is administered intravenously. Rituximab is also given intravenously. The specific dosage and frequency are determined by the study protocol.

Participants in the control group receive standard immunochemotherapy, which may include medications such as dexamethasone (oral use), oxaliplatin, and gemcitabine (both intravenous use).

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and laboratory assessments.

Follow-up visits are scheduled to track progression-free survival, which is the time between randomization and the first documentation of disease recurrence, progression, or death.

5 completion of study

The study is estimated to conclude by February 2026. Participants will continue to be monitored for outcomes related to the primary endpoint of progression-free survival.

Who Can Join the Study?

Must be a male or female patient aged 18 years or older.
Women who can have children must agree to use a very effective birth control method from the time they agree to join the study until at least 12 months after their last dose of the study treatment. Men with female partners who can have children must agree to use a condom or not have sexual activity from the time they agree to join the study until at least 7 months after their last dose of the study treatment.
Must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or a similar type of lymphoma, as defined by the 2016 World Health Organization classification. This includes patients whose DLBCL has changed from a slower-growing type of lymphoma.
Must have a disease that has come back after treatment or did not respond to at least one previous treatment that involved multiple drugs.
Must not be considered suitable for stem cell transplantation due to factors like overall health, age, or other significant health issues.
Must have a disease that can be measured using specific imaging tests like PET-CT, CT, or MRI scans.
Must have available tumor tissue samples for testing. If multiple samples are available, the most recent one is preferred.
Must have an ECOG performance status of 0-2, which is a scale used to assess how a patient’s disease is affecting their daily living abilities.
Must have adequate organ function based on specific laboratory test results, including:
- A certain level of neutrophils (a type of white blood cell) without recent use of growth factors.
- A certain level of platelets (cells that help with blood clotting) without recent transfusions.
- Levels of liver enzymes (ALT, AST, GGT) within a specific range.
- Total bilirubin within a specific range, with some exceptions for patients with known Gilbert’s syndrome.
- Creatinine clearance (a measure of kidney function) at a certain level, calculated using a specific formula.
Women who can have children must have a negative pregnancy test within 7 days before starting the study drug.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate cannot participate.

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
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Del Mar	Barcelona	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Elisabeth-Tweesteden Ziekenhuis	Tilburg	The Netherlands
Universita Degli Studi Di Brescia	Brescia	Italy
Centre Henri Becquerel	Rouen	France
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Hôpital Avicenne	Bobigny	France
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Semmelweis University	Budapest	Hungary
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Pratia S.A.	Skorzewo	Poland
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
University Hospital Ostrava	Ostrava	Czechia
L’Hopital Prive Du Confluent	Nantes	France
Clxjegmua Ubzhpcllvtitgh Sguityesj	Woluwe-Saint-Lambert	Belgium
Hdznoucg Ulreyqxbfkclh Miepbqr Df Vcdvzmunwu	Santander	Spain
Iwksqnlf Cimqfr Dkcmwqsumwgwulfld	L'hospitalet De Llobregat	Spain
Sjfuvbyf Pnaaslley Sxy z otos	Gdynia	Poland
Altsyrn Sjj z ohwi	Poznan	Poland
Fizsoorm njwonotbd Mvwuv a Hxcmlid	Prague	Czechia
Iupopsfr Rmwgusbvz Prn Lk Snbfkq Dbw Tqcwui Dewp Adggbyv Iqeh Sirhli	Meldola	Italy
Fhzblibgc Pjur Li Iqwosbhqaftlq Bokpuacsi Dar Hwlatzev Uctnmjnvuxiqx Lu Pui	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	21.04.2021
Czechia	Not recruiting	21.04.2021
France	Not recruiting	21.04.2021
Hungary	Not recruiting	21.04.2021
Italy	Not recruiting	21.04.2021
Poland	Not recruiting	21.04.2021
Spain	Not recruiting	21.04.2021
The Netherlands	Not recruiting	21.04.2021

Trial locations

Investigated drugs:

Loncastuximab Tesirine is a medication being studied for its effectiveness in treating patients with a type of cancer called diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to previous treatments. It works by targeting and delivering a toxic substance directly to the cancer cells, which may help to kill them.

Rituximab is a medication used in combination with other treatments to help manage certain types of cancer, including DLBCL. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

Investigated diseases:

Diffuse large B-cell lymphoma

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can progress quickly, requiring prompt medical attention. It is the most common subtype of non-Hodgkin lymphoma and can occur at any age, though it is more frequently diagnosed in older adults. The progression of the disease can vary, with some cases responding well to treatment while others may be more challenging to manage.

Trial ID:

2023-503916-33-00

Protocol code:

ADCT-402-311

NCT ID:

NCT04384484

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Loncastuximab Tesirine and Rituximab with Standard Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?