Study of Pembrolizumab and Chemotherapy for Patients with Newly Diagnosed Classical Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Classical Hodgkin Lymphoma, which is a cancer of the lymphatic system. The study is investigating the effects of a treatment that combines a medication called Pembrolizumab with various chemotherapy drugs. Pembrolizumab, also known by its code name MK-3475, is a type of medication that helps the immune system fight cancer cells. The chemotherapy drugs used in this study include Doxorubicin, Etoposide, Vinblastine Sulfate, Bleomycin, Prednisolone, Anhydrous Cyclophosphamide, Dacarbazine, and Procarbazine. These drugs are commonly used to treat various types of cancer by killing or stopping the growth of cancer cells.

The purpose of this study is to evaluate how well the combination of Pembrolizumab and chemotherapy works in treating patients who have been newly diagnosed with Classical Hodgkin Lymphoma. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants’ response to the treatment over a period of time, assessing how effectively the cancer is being controlled or reduced.

Throughout the study, participants will be closely observed to track their progress and any side effects they may experience. The goal is to determine the complete response rate, which refers to the disappearance of all signs of cancer in response to the treatment. This information will help researchers understand the potential benefits and risks of using Pembrolizumab in combination with chemotherapy for treating Classical Hodgkin Lymphoma.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Blood tests and imaging studies, such as a PET scan, may be performed to assess the extent of the disease.

2 treatment phase 1

The first phase of treatment involves the administration of chemotherapy drugs. These drugs include doxorubicin, etoposide, vinblastine sulfate, bleomycin, vincristine, cyclophosphamide, dacarbazine, and procarbazine. They are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The specific dosage and frequency of these medications will be determined by the study protocol and the healthcare team.

3 treatment phase 2

In addition to chemotherapy, pembrolizumab (also known as Keytruda) will be administered. This is a type of immunotherapy that helps the immune system fight cancer cells.

Pembrolizumab is given as an intravenous infusion. The frequency and duration of this treatment will be specified by the study protocol.

4 oral medication

Prednisone is an oral medication that will be taken as part of the treatment regimen. The dosage and schedule for taking prednisone will be provided by the healthcare team.

It is important to follow the instructions for taking prednisone carefully to ensure the best possible outcome.

5 monitoring and follow-up

Throughout the study, regular monitoring will be conducted to assess the response to treatment. This may include physical exams, blood tests, and imaging studies.

The healthcare team will also monitor for any side effects or adverse events related to the treatment.

6 end of study assessment

At the end of the study intervention, a final assessment will be conducted to evaluate the complete response to treatment. This will be done according to specific criteria set by the study.

The results of this assessment will help determine the effectiveness of the treatment regimen.

Who Can Join the Study?

The patient must have a confirmed diagnosis of classical Hodgkin Lymphoma at Stage III or IV. Patients with Stage I or II can join if they have at least one unfavorable risk factor as defined by the National Comprehensive Cancer Network (NCCN).
The patient must have a disease that can be measured and shows activity on a special scan called 2-fluorodeoxyglucose (FDG)-avid scan, as assessed by the doctor.
The patient must not have received any previous treatments like radiation therapy, chemotherapy, immunotherapy, or other systemic therapies for classical Hodgkin Lymphoma before starting the study treatment.
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, which means they are fully active or have some symptoms but do not need bed rest for more than half of the day. This will be checked within 7 days before starting the study treatment.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Classical Hodgkin Lymphoma.
Patients who have already received treatment for Classical Hodgkin Lymphoma.
Patients who are pregnant or breastfeeding.
Patients who have a serious infection that is not controlled.
Patients who have a history of another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer.
Patients who have a known allergy to any of the study medications.
Patients who have a significant heart condition that is not stable.
Patients who have a serious mental health condition that might affect their ability to participate in the study.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse within the last year.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Centre Henri Becquerel	Rouen	France
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Ciacry Hgelgvykteb Udgrtyklwtbrn Dg Dnygk	Dijon	France
Aoquxfx Ujfhc Sqyxorntm Luemcy Da Baxaljo	Bologna	Italy
Umvvygfrecgrbj Cinbxqr Kuipdewrm	Gdansk	Poland
Ixxpdnvu Cwqigd Dphugueojnmftrcri	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.11.2021
Italy	Not recruiting	08.11.2021
Poland	Not recruiting	08.11.2021
Spain	Not recruiting	08.11.2021

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used to treat patients with a type of cancer called classical Hodgkin Lymphoma. The goal is to see if it can help the body fight the cancer more effectively when used alongside chemotherapy.

Chemotherapy is a treatment that uses powerful drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is combined with pembrolizumab to see if the combination can improve the treatment outcomes for patients with classical Hodgkin Lymphoma. Chemotherapy targets rapidly dividing cells, which include cancer cells, and aims to reduce or eliminate the cancer.

Classical Hodgkin Lymphoma – Classical Hodgkin Lymphoma 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 typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, bone marrow, and lungs. As it progresses, it may cause symptoms such as 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 course of the disease is influenced by various factors, including the stage at diagnosis and the specific characteristics of the cancer cells.

Trial ID:

2022-501615-14-00

Protocol code:

MK-3475-C11

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab and Chemotherapy for Patients with Newly Diagnosed Classical Hodgkin Lymphoma

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