Study of Pembrolizumab with Chemotherapy for Children and Young Adults with Classical Hodgkin Lymphoma Not Responding Well to Initial Treatment

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What is this study about?

This clinical trial is focused on studying a type of cancer called Classical Hodgkin Lymphoma in children and young adults. The trial is testing a treatment that includes a medication called pembrolizumab, also known by its code name MK-3475. Pembrolizumab is used in combination with chemotherapy for patients who have not responded well to initial treatments. The chemotherapy drugs involved in this study include doxorubicin, vinblastine, dacarbazine, cyclophosphamide, vincristine, prednisone, and prednisolone. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well the combination of pembrolizumab and chemotherapy works in treating patients with slow early response to initial treatment. Participants will receive the study treatment over a period of time, and their response to the treatment will be monitored. The study will also compare the effectiveness of different chemotherapy combinations, such as AVD (doxorubicin, vinblastine, and dacarbazine) and COPDAC-28 (cyclophosphamide, vincristine, prednisone, and dacarbazine), in achieving a negative result on a PET scan, which is a type of imaging test that helps doctors see how the cancer is responding to treatment.

Throughout the study, researchers will track various outcomes, including the rate of response to treatment, survival rates, and any side effects experienced by participants. The study aims to provide valuable information on the best treatment options for children and young adults with Classical Hodgkin Lymphoma who do not respond well to initial chemotherapy. The trial is expected to continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm the diagnosis of classical Hodgkin lymphoma. This includes a review of medical history and a physical examination.

Eligibility is determined based on specific criteria, such as disease stage and measurable disease presence.

2 treatment initiation

Treatment begins with the administration of pembrolizumab through an intravenous infusion. This medication is given to evaluate its effectiveness in combination with chemotherapy.

The treatment plan is tailored based on the risk group classification (low or high) and the patient’s response to initial chemotherapy.

3 chemotherapy regimen

Chemotherapy involves a combination of medications administered through intravenous infusion. These include bleomycin, vinblastine sulfate, etoposide, cyclophosphamide, doxorubicin, and dacarbazine.

Oral medications such as prednisolone and prednisone are also part of the regimen. The specific combination and dosage depend on the treatment protocol assigned.

4 monitoring and evaluation

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests like PET scans to evaluate disease status.

The objective response rate is measured to determine the effectiveness of the treatment.

5 adjustments and follow-up

Based on the response to treatment, adjustments may be made to the therapy plan. This could involve changes in medication dosage or frequency.

Follow-up visits are scheduled to monitor long-term outcomes and manage any side effects or complications.

6 completion of trial

The trial is expected to conclude by November 2028. At this point, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

Participants are provided with a summary of their treatment outcomes and any necessary follow-up care instructions.

Who Can Join the Study?

Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma. This is a type of cancer that affects the lymphatic system.
For Group 1: Must be at Stages IA, IB, and IIA without bulky disease. Bulky disease means large tumors.
For Group 2: Must be at Stages IIEB, IIIEA, IIIEB, IIIB, IVA, and IVB.
Must have measurable disease. This means the cancer can be measured by the doctor.
Male participants must agree to either not have heterosexual intercourse or use contraception, unless they are confirmed to be azoospermic. Azoospermic means not producing sperm.
Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use approved contraception during the study and for at least 120 days after the last dose. They also agree not to donate or store eggs for reproduction during this time.
Must have a performance status of at least 50 on the Lansky Play-Performance Scale for children up to 16 years old, or a Karnofsky score of at least 50 for those 16 years and older. These scores measure how well a person can perform daily activities.
Must have adequate organ function. This means the organs are working well enough to participate in the study.

Who Cannot Join the Study?

Patients who do not have Classical Hodgkin lymphoma, which is a type of cancer affecting the lymphatic system, cannot participate.
Individuals who are not children or young adults are excluded, as the study is only for these age groups.
Participants who are not classified as slow early responders (SERs) to treatment, meaning they do not respond slowly to initial treatment, are not eligible.
People who do not fit into the specified risk groups (low or high) for the study are excluded.
Both males and females can participate, so exclusion is not based on gender.
Individuals who are not part of a vulnerable population, which includes groups that may need special protection, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Robert Debre University Hospital	Paris	France
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou	Athens	Greece
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon	Naples	Italy
Hospices Civils De Lyon	Lyon	France
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Assistance Publique Hopitaux De Paris	Paris	France
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Pellegrin Hospital	Bordeaux	France
Nosokomeio Paidon I Agia Sofia	Athens	Greece
Narodny Ustav Detskych Chorob	Bratislava	Slovakia
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Hopital Jeanne De Flandre	Lille	France
Aoaveph Omhggndzydz Ujispobhgppsh Ckxbgivjwpdo Dqpid Smadzr E Dkhyn Sawcovm Du Tmarmv	Turin	Italy
Uporwqfpijyyccwdkuqsh Mxoxssmd Apq	Munster	Germany
Fmxpopsv nfbvkjpho Mgwup a Hlsbigc	Prague	Czechia
Aktezfdlcj Pzqdxrwp Hsrfgwmv Dt Moyrubngi	Marseille	France
Kejwggwx drz Uzroebguhqpy Macewrvl Ayn	Munich	Germany
Udhycvshelmnzewfqxmih Efdzk Ayz	Essen	Germany
Uhmzaxjjfd Dlicq Sduhr Dh Ryuh Lj Skmblfdm	Rome	Italy
Fflnrolap Pefj Lu Ivyswoymeqyiw Bcnagypze Dwr Hicnzlnn Ushrvzhbmpkjl Lx Pwb	Madrid	Spain
Hlssthhl Vipu dzeowncg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	06.11.2019
France	Not recruiting	06.11.2019
Germany	Not recruiting	06.11.2019
Greece	Not recruiting	06.11.2019
Italy	Not recruiting	06.11.2019
Slovakia	Not recruiting	06.11.2019
Spain	Not recruiting	06.11.2019
The Netherlands	Not recruiting	06.11.2019

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. In this study, pembrolizumab is being tested in children and young adults with a type of cancer called classical Hodgkin lymphoma, especially in those who did not respond well to initial chemotherapy.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with pembrolizumab to treat patients with classical Hodgkin lymphoma. The goal is to improve the response to treatment in patients who did not have a strong response to the first round of chemotherapy.

Classical Hodgkin Lymphoma in Children and Young Adults – This is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some individuals experiencing slow growth of the cancer, while others may have a more aggressive form. The condition is more common in children and young adults, and its progression can be influenced by various factors, including the individual’s overall health and the specific characteristics of the cancer.

Trial ID:

2023-504821-38-00

Protocol code:

MK-3475-667

NCT ID:

NCT03407144

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab with Chemotherapy for Children and Young Adults with Classical Hodgkin Lymphoma Not Responding Well to Initial Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?