Study of Nivolumab for Early Stage Hodgkin Lymphoma in Patients with Good Prognosis

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called Hodgkin Lymphoma, specifically in its early stages when the disease is not widespread and does not show severe symptoms. The trial aims to explore the effectiveness of a treatment approach that does not involve radiation. Instead, it uses chemotherapy alone for patients who are considered to have a good prognosis. This means that the patients have a low risk of the disease worsening, as determined by specific tests that measure the size of the tumor and its activity after two cycles of chemotherapy.

The study will also investigate the use of a medication called Nivolumab for patients who are at a higher risk of the disease progressing. Nivolumab is given through an infusion, which means it is administered directly into the bloodstream. The trial will look at how well this medication works in combination with chemotherapy for those who do not respond as well to the initial treatment. The goal is to see if this combination can help prevent the disease from coming back or getting worse over a period of three years.

Participants in the study will undergo regular monitoring to track their progress and response to the treatment. The study will assess the safety and effectiveness of the treatment plan, including the use of Nivolumab, to determine if it can improve outcomes for patients with early-stage Hodgkin Lymphoma. The trial will continue until 2026, with the aim of providing valuable insights into the best treatment strategies for this type of cancer.

1 initial assessment

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

Blood tests are performed to check levels of bilirubin, ALT, AST, hemoglobin, neutrophils, platelets, and creatinine.

2 chemotherapy cycles

The treatment begins with two cycles of chemotherapy using a regimen known as ABVD. This includes the drugs doxorubicin, bleomycin, vinblastine, and dacarbazine.

Each cycle lasts for 28 days, with the medication administered on specific days within the cycle.

3 interim PET scan

After completing the two chemotherapy cycles, a PET scan is conducted. This scan helps to assess the response to the treatment by measuring the metabolic activity of the tumor.

4 treatment evaluation

The results of the interim PET scan determine the next steps. If the scan is negative, indicating a good response, the treatment may continue with chemotherapy alone.

If the scan is positive, indicating a higher risk, additional treatment with nivolumab may be considered.

5 nivolumab administration

For patients requiring additional treatment, nivolumab is administered. This medication is given through an intravenous infusion.

The frequency and duration of nivolumab administration depend on the individual treatment plan.

6 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor health and response to treatment. This includes physical exams, blood tests, and imaging studies as needed.

The follow-up period aims to evaluate the long-term efficacy and safety of the treatment.

Who Can Join the Study?

Patients must be male or female and aged between 18 and 70 years.
The level of total bilirubin in the blood must be less than 2 times the upper limit of normal, unless the patient has a known condition called Gilbert syndrome.
The levels of liver enzymes ALT or AST must be less than 3 times the upper limit of normal.
Female patients must either be postmenopausal for at least 1 year or, if they can have children, agree to use 2 effective methods of birth control or agree to not have sexual intercourse.
Male patients must agree to use barrier methods of birth control or agree to not have sexual intercourse.
Patients must not have received any treatment for classical Hodgkin Lymphoma and must have early-stage disease (stage I or II A) without large tumors, as defined by specific criteria.
Patients must have a confirmed diagnosis of classical Hodgkin Lymphoma according to the World Health Organization’s classification.
Patients must have an ECOG performance status of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
Patients must have a hemoglobin level greater than 8 grams per deciliter.
Patients must have an absolute neutrophil count of at least 1,000 per microliter, which is a measure of a type of white blood cell important for fighting infections.
Patients must have a platelet count of at least 100,000 per microliter, which is important for blood clotting.
Patients must voluntarily provide written consent to participate in the study.
The level of serum creatinine must be less than 2.0 milligrams per deciliter, and/or the creatinine clearance must be greater than 40 milliliters per minute, which are measures of kidney function.

Who Cannot Join the Study?

Patients with bulky lesions. These are large areas of cancer that can be seen on scans.
Patients with constitutional symptoms. These are general symptoms like fever, night sweats, or weight loss.
Patients who do not have a low MTV. MTV stands for Metabolic Tumor Volume, which is a measure of how much cancer is in the body.
Patients who do not have a negative interim PET after 2 courses of ABVD. A PET scan is a type of imaging test that helps show how the cancer is responding to treatment. ABVD is a common chemotherapy treatment for Hodgkin Lymphoma.
Patients who are not in the early stage I-IIA of Hodgkin Lymphoma. This refers to the early stages of the disease.
Patients who are not considered low-risk. This means they have factors that make their cancer more likely to come back or be harder to treat.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Azienda Ulss 3 Serenissima	Venice	Italy
Universita Degli Studi Di Cagliari	Cagliari	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Hospital Universitario De Leon	Leon	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Universita Degli Studi Di Brescia	Brescia	Italy
Servei De Salut De Les Illes Balears	Palma	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hatdebcj Uecmxvlbzcypz Maqqien Do Vadwbuderi	Santander	Spain
Izbqqhnb Cnjzzh Dgmhvugedrpfpjfzz	L'hospitalet De Llobregat	Spain
Atrvyee Oaejuutaevo Oxupxhij Roqpyom Vdlhb Saxwk Cbzwtpnt	Palermo	Italy
Nactpeqs Ijujzcni Ommhwfofl Icj Mcmqe Sgcxqfieecornxlnmfwrbssthaxh Iuvausut Bajlnzcg	Cracow	Poland
Uoxloeqrrkptrc Craonte Kadqhglnz	Gdansk	Poland
Anuhejl Olbuiikqajx Phzr Gguvsbfk Xmmxw	Bergamo	Italy
Honzraux Vqyo dzrwtvdz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.02.2021
Poland	Recruiting	01.02.2021
Spain	Recruiting	01.02.2021

Trial locations

Investigated drugs:

Nivolumab

ABVD is a combination chemotherapy regimen used to treat Hodgkin’s lymphoma. It includes four different medications that work together to kill cancer cells and stop them from growing. This regimen is often used as an initial treatment for patients with early-stage Hodgkin’s lymphoma. The goal of using ABVD in this trial is to determine if it can effectively treat patients without the need for radiation therapy, especially in those with a good prognosis.

Early Stage Classical Hodgkin Lymphoma – This is a type of cancer that affects the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a type of abnormal cell. In its early stages, the disease may not present with bulky lesions or constitutional symptoms like fever, night sweats, or weight loss. The progression of the disease can vary, but it typically involves the spread of cancerous cells to nearby lymph nodes. The disease is often detected through imaging tests and biopsies, which reveal the characteristic cells. Early-stage Hodgkin Lymphoma is generally considered more manageable than advanced stages.

Trial ID:

2024-515063-66-00

Protocol code:

NBK132/1/2020

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Nivolumab for Early Stage Hodgkin Lymphoma in Patients with Good Prognosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?