Phase III Trial Comparing ABVD vs A2VD Treatment With PET-Guided Radiation Therapy for Patients With Early Stage Hodgkin Lymphoma

3 1 1 1

What is this study about?

This clinical trial is studying stage IA/IIA Hodgkin lymphoma, a type of blood cancer affecting the lymphatic system. The study compares two chemotherapy regimens: the standard ABVD (a combination of doxorubicin, bleomycin, vinblastine, and dacarbazine) versus A2VD (which modifies the standard regimen). Both treatments may be combined with ISRT (involved-site radiation therapy). The trial uses a PET-response adapted design, meaning that treatment decisions are guided by results from PET scans (a type of imaging that shows how tissues are functioning) after initial cycles of chemotherapy.

The purpose of this research is to determine if the modified chemotherapy regimen (A2VD) can improve how long patients remain free from disease progression compared to the standard treatment. Patients will receive either ABVD or A2VD chemotherapy, and depending on their response as shown on PET scans after two treatment cycles, they may continue with the same treatment or receive additional radiation therapy.

This study is designed for patients with early-stage Hodgkin lymphoma who have not received previous treatment for their disease. The study will monitor patients for treatment effectiveness, side effects, and long-term outcomes including the development of second cancers and heart disease.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be asked to provide written consent to participate.

You will undergo initial assessments to confirm eligibility, including blood tests and imaging scans.

2 treatment phase 1

You will begin the first phase of treatment, which involves receiving a combination of medications. These medications are administered through an intravenous (IV) line, which means they are given directly into your bloodstream.

The medications include vinblastine sulfate, dacarbazine, bleomycin, and doxorubicin hydrochloride. The specific dosages and frequency will be determined by your healthcare team.

3 PET scan assessment

After completing two cycles of the initial treatment, you will undergo a PET scan. This scan helps assess how well the treatment is working by checking for changes in the activity of the lymphoma.

Based on the results of the PET scan, your treatment plan may be adjusted.

4 treatment phase 2

Depending on the PET scan results, you may continue with the same treatment or switch to a different combination of medications. This may include brentuximab vedotin and filgrastim, which is given subcutaneously (under the skin).

The treatment will continue for a specified duration, with regular monitoring and assessments.

5 follow-up and monitoring

Throughout the trial, you will have regular follow-up appointments to monitor your health and the effectiveness of the treatment.

These appointments may include physical exams, blood tests, and imaging scans to ensure the treatment is working and to check for any side effects.

6 end of trial

At the end of the trial, you will have a final assessment to evaluate the overall outcome of the treatment.

You will receive information about any further treatment or follow-up care that may be necessary.

Who Can Join the Study?

Men and women aged 16 to 69 years. For some centers, the age range is 18 to 69 years.
Must have adequate bone marrow function, which means having enough healthy blood cells. Specifically, neutrophils (a type of white blood cell) should be at least 1.0 x 10⁹/l and platelets (cells that help with blood clotting) should be at least 100 x 10⁹/l.
Hemoglobin (a protein in red blood cells that carries oxygen) should be at least 8g/dl.
Must be willing and able to follow the study requirements, including advice on birth control if needed.
Must provide written informed consent, which means agreeing to participate after understanding the study details.
Must have a confirmed diagnosis of classical Hodgkin lymphoma through a tissue sample examination.
Must have stage I or II disease located above the diaphragm (the muscle that helps with breathing) without large tumors in the chest area. Large tumors are defined as greater than a third of the chest width at any level of the thoracic spine as seen on a CT scan. Large tumors in other areas are acceptable. Disease that has spread to one nearby area outside the lymph nodes is also acceptable.
Must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
Must not have received any previous treatment for Hodgkin lymphoma.
Must be fit to receive anthracycline-based chemotherapy, a type of cancer treatment. If there is a history of heart disease or high blood pressure, the heart’s pumping ability should be at least 50%.
Creatinine clearance (a measure of kidney function) should be more than 40 ml/min.
Total bilirubin (a substance made by the liver) should be less than 1.5 times the upper limit of normal, unless it is due to the disease or a known condition called Gilbert’s syndrome.
ALT or AST (enzymes that indicate liver health) should be less than 2 times the upper limit of normal.

Who Cannot Join the Study?

Patients with a different type of cancer than stage IA/IIA Hodgkin lymphoma cannot participate. This is a specific type of cancer affecting the lymphatic system.
Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding may not be eligible to participate, as the study may involve treatments that could affect the baby.
Patients who have participated in another clinical trial recently may not be eligible, as this could affect the study results.
Patients with certain medical conditions that could interfere with the study or make participation unsafe may be excluded.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Narodny Onkologicky Ustav	Bratislava	Slovakia
University Hospital Galway	Galway	Ireland
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Gasthuiszusters Antwerpen	Antwerp	Belgium
Reinier de Graaf Groep	Delft	The Netherlands
Medical Center Haaglanden	Leidschendam	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Hospital Del Mar	Barcelona	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Uhdwcwmebjwt Misgfib Cajekjx Gtcmsuwev	Groningen	The Netherlands
Afqzggxqf Ujx	Amsterdam	The Netherlands
Abyglw Upthgfdahx Hpkhmgxl	Aarhus	Denmark
So Vzgvzwsyfwccwux Uubneksfqi Hinpjwih	Dublin	Ireland
Uazavcucjw On Anqedwe	Edegem	Belgium
Ilxlopys Cvlfoj Dexeadwlvlltjqpjr	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.06.2023
Denmark	Recruiting	15.06.2023
Ireland	Recruiting	15.06.2023
Portugal	Recruiting	15.06.2023
Slovakia	Recruiting	15.06.2023
Spain	Recruiting	15.06.2023
The Netherlands	Recruiting	15.06.2023

Trial locations

Investigated drugs:

ABVD is a combination of four different drugs used to treat Hodgkin lymphoma. These drugs work together to stop cancer cells from growing and dividing. The combination includes a medicine that damages the DNA of cancer cells, a medicine that interferes with the growth of cancer cells, a medicine that stops cancer cells from making proteins they need to grow, and a medicine that helps the immune system fight cancer.

A2VD is another combination of drugs used in the treatment of Hodgkin lymphoma. This combination is being studied to see if it can improve outcomes for patients compared to the traditional ABVD treatment. Like ABVD, A2VD works by targeting cancer cells in different ways to stop them from growing and spreading.

ISRT stands for involved-site radiation therapy. This therapy uses high-energy rays to target and kill cancer cells in specific areas of the body where the cancer is located. ISRT is often used in combination with chemotherapy to help improve the chances of eliminating the cancer.

Stage IA/IIA Hodgkin Lymphoma – Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. In stage IA, the cancer is found in a single lymph node region or a single organ. In stage IIA, the cancer is in two or more lymph node regions on the same side of the diaphragm, which is the muscle under the lungs that helps with breathing. The disease progresses by spreading to nearby lymph nodes and potentially to other parts of the body. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss.

Trial ID:

2022-500031-37-00

Protocol code:

UCL/15/0105

NCT ID:

NCT04685616

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Phase III Trial Comparing ABVD vs A2VD Treatment With PET-Guided Radiation Therapy for Patients With Early Stage Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?