Study of drug combination therapy in children and adolescents with relapsed or refractory B-cell non-Hodgkin lymphoma using odronextamab, loncastuximab tesirine and rituximab

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What is this study about?

This clinical trial is studying treatments for B-cell Non-Hodgkin Lymphoma that has come back or not responded to previous treatments in children and young adults. The study will test several medications including odronextamab, loncastuximab tesirine, and combinations of chemotherapy drugs including rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone.

The purpose of this study is to evaluate how well these treatments work in patients whose lymphoma has returned or did not respond to initial treatment. The study is divided into different treatment groups, with some patients receiving new targeted therapies while others receive combinations of standard chemotherapy medications.

During the study, patients will receive their assigned treatment and have regular medical evaluations to check how well the treatment is working. The treatment period may last up to 24 months, depending on which medication group the patient is assigned to. Doctors will monitor patients’ response to treatment using imaging scans and other medical tests to assess if the cancer is responding to the therapy.

1 Initial treatment preparation

Your eligibility for the trial will be confirmed through medical tests, including blood tests to check bone marrow function

A pregnancy test will be performed if applicable

Your disease will be evaluated through imaging tests (CT or MRI) to measure the affected areas

2 Treatment assignment

You will be assigned to one of three treatment groups:

Treatment Arm I: Treatment with a medication called odronextamab given by intravenous infusion

Treatment Arm II: Treatment with a combination of medications including rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone (modified R-ICE), given by infusion

Treatment Arm III: CAR T-cell therapy for eligible patients

3 Treatment period

For Treatment Arm I: Treatment will be evaluated after 12 weeks to check if there is improvement in your condition

For Treatment Arm II: You will receive up to three cycles of treatment

Regular imaging tests will be performed to monitor how your disease responds to treatment

Blood tests will be conducted to monitor your health during treatment

4 Follow-up period

Your health will be monitored for any side effects from the treatment

Regular check-ups will track how long the treatment response lasts

Long-term monitoring will continue to assess your overall health and disease status

Who Can Join the Study?

Patient must have confirmed mature B-cell non-Hodgkin Lymphoma (a type of blood cancer) that has either come back after treatment or did not respond to previous treatments
Patient must be from birth to 25 years old at the time of joining the study
Patient must have disease that can be measured through scans or bone marrow tests
Patient must have good enough physical function (ability to perform daily activities)
Patient must have a life expectancy of at least 8 weeks
Patient must have adequate blood cell counts:
– Sufficient platelets (cells that help blood clot)
– Sufficient neutrophils (white blood cells that fight infection)
Female patients who can become pregnant must have a negative pregnancy test within 7 days before starting
Patients who can have children must:
– Use effective birth control during treatment and for 12 months after
– Not donate eggs or sperm during treatment and for 12 months after
Patient must have adequate kidney function
Patient must have adequate liver function
If patient had previous cell therapy treatments, they must have recovered from side effects and still have measurable disease
Patient or their legal guardian must provide written informed consent

Who Cannot Join the Study?

Active central nervous system disease, including brain or spinal cord involvement
History of other cancer types within the past 3 years (except for successfully treated skin cancer or early-stage cervical cancer)
Severe heart problems, including heart failure (when heart cannot pump blood effectively) or uncontrolled irregular heartbeat
Severe lung problems that affect breathing
Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
Severe liver problems affecting liver function
Severe kidney problems affecting kidney function
Pregnancy or breastfeeding
Previous treatment with similar therapy in the past 30 days
Mental conditions that would interfere with understanding study requirements
Participation in another clinical trial within the past 30 days
Known allergic reactions to study medications or similar compounds
Uncontrolled high blood pressure
Major surgery within the past 4 weeks
Any condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
St. Anna Kinderspital GmbH	Vienna	Austria
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Pellegrin Hospital	Bordeaux	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Ikboxjlj dytojqceotobtbqdllj eo dwtaubjsgtigefixd Pauefvuzgiw (tbhgb	Lyon	France
Felpyspuf Plcx Lw Izyvbtpceekvz Butggrayu Dmy Htzsioip Ujdcppacydsrm Ly Pmq	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.05.2025
Belgium	Not yet recruiting	01.05.2025
France	Not yet recruiting	01.05.2025
Spain	Not yet recruiting	01.05.2025
Sweden	Not yet recruiting	01.05.2025
The Netherlands	Not yet recruiting	01.05.2025

Trial locations

Investigated drugs:

BsAb (Bispecific Antibody) is a type of treatment that helps the body’s immune system fight cancer cells. It works by connecting immune cells to cancer cells, making it easier for the immune system to recognize and destroy the cancer.

Rituximab is a medication that targets specific proteins on B-cells (a type of white blood cell) to help fight lymphoma. It works with the body’s immune system to kill cancer cells.

Ifosfamide is a chemotherapy medication that works by stopping cancer cells from growing and dividing.

Carboplatin is a chemotherapy medication that interferes with cancer cell DNA, preventing cancer cells from multiplying.

Etoposide is a chemotherapy medication that blocks enzymes needed for cancer cell growth, causing the cells to die.

Dexamethasone is a steroid medication that helps reduce inflammation and suppress immune system responses, often used alongside chemotherapy to help manage side effects.

CAR T-cell therapy is a treatment where a patient’s own immune cells (T-cells) are modified in a laboratory to better recognize and fight cancer cells. These modified cells are then returned to the patient’s body to attack the lymphoma.

ADC (Antibody-Drug Conjugate) is a targeted therapy that combines an antibody with a chemotherapy drug. The antibody helps deliver the chemotherapy directly to cancer cells, potentially reducing side effects on healthy cells.

Non-Hodgkin Lymphoma – A type of blood cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. The disease occurs when abnormal lymphocytes grow and multiply uncontrollably, usually beginning in lymph nodes or other lymphatic tissue. In mature B-cell non-Hodgkin lymphoma specifically, the cancer develops in B lymphocytes that have reached their mature form. The disease can spread throughout the lymphatic system, affecting multiple areas of the body. When the condition becomes relapsed and refractory, it means the lymphoma has returned after treatment or has stopped responding to standard treatments.

Trial ID:

2024-510575-38-00

Protocol code:

RG_21-124

NCT ID:

NCT05991388

Trial Phase:

Therapeutic use (Phase IV)

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Study of drug combination therapy in children and adolescents with relapsed or refractory B-cell non-Hodgkin lymphoma using odronextamab, loncastuximab tesirine and rituximab

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?