Study on the Effect of DA-EPOCH-R and Nivolumab in Patients with Newly Diagnosed High-Grade B-Cell Lymphoma with MYC and BCL2/BCL6 Rearrangements

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), specifically a high-grade form with certain genetic changes known as MYC and BCL2 and/or BCL6 rearrangements. The study aims to evaluate the effectiveness of a treatment regimen called DA-EPOCH-R, which includes a combination of medications: Rituximab, Doxorubicin Hydrochloride, Vincristine Sulfate, Cyclophosphamide, Etoposide, and Prednisolone. After this initial treatment, patients will receive a medication called Nivolumab (also known by its code name BMS936558) as a follow-up treatment to help prevent the cancer from returning.

The purpose of the study is to see if adding Nivolumab after the initial treatment can improve the chances of the cancer not coming back within 12 months. Participants will first receive the DA-EPOCH-R treatment, which involves a series of medications given through an infusion into a vein, and Prednisolone taken as a tablet. This phase lasts for about 18 weeks. After completing this phase, patients will receive Nivolumab infusions for up to 52 weeks. Some participants may receive a placebo instead of Nivolumab to compare the outcomes.

The study will monitor the participants’ health and response to the treatment through regular check-ups and imaging tests like PET-CT scans, which help visualize the cancer’s activity in the body. The goal is to determine if the combination of treatments can increase the time patients remain free of cancer. This study is important for understanding how to better treat this aggressive form of lymphoma and improve patient outcomes.

1 beginning of treatment

Upon joining the clinical trial, you will start with a treatment called DA-EPOCH-R. This involves a combination of medications administered over several days.

The medications include rituximab, doxorubicin hydrochloride, prednisolone, vincristine sulfate, etoposide, and cyclophosphamide. Most of these are given through a vein, which is known as intravenous use.

2 medication administration

The treatment cycle typically lasts for 21 days. During this time, you will receive the medications on specific days as part of the cycle.

Rituximab, doxorubicin hydrochloride, vincristine sulfate, etoposide, and cyclophosphamide are given intravenously. Prednisolone is taken orally, which means you will swallow it in pill form.

3 monitoring and assessments

Throughout the treatment, regular monitoring will be conducted to assess your response to the medications. This includes imaging tests like 18F-FDG PET-CT scans to check the status of the disease.

These assessments help determine how well the treatment is working and guide any necessary adjustments.

4 nivolumab consolidation

After completing the initial treatment cycles, you will receive a medication called nivolumab as a consolidation therapy. This is also given intravenously.

The purpose of this phase is to help maintain the response achieved from the initial treatment and to increase the chances of long-term disease-free survival.

5 follow-up and conclusion

Following the completion of all treatment phases, regular follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.

These visits are important to ensure any changes in your condition are promptly addressed and to gather information on the effectiveness of the treatment over time.

Who Can Join the Study?

Must have a type of lymphoma called High-grade B-cell lymphoma, which involves specific genetic changes known as MYC, BCL2, and/or BCL6 rearrangements. This is determined by a test called FISH.
Must provide written informed consent, meaning you agree to participate after understanding the study details.
Must be able to give informed consent, meaning you understand what participation involves.
Must be 18 years or older.
Must have started or completed one course of specific chemotherapy treatments called R-CHOP or DA-EPOCH-R. Certain conditions apply to these treatments.
Must have a WHO performance status of 0-3, which is a measure of your ability to perform daily activities, during or after the first treatment cycle.
Must have been diagnosed at Ann Arbor stage II-IV, which describes the extent of lymphoma in the body.
Must have had a specific type of scan called an 18F-FDG PET scan and a contrast-enhanced CT scan done, preferably within 28 days before starting the first treatment cycle.
Must have measurable disease, meaning at least one tumor or lymph node that can be measured on a CT scan and shows activity on a PET scan.
If female, must have a negative pregnancy test at the start of the study.
Must be willing and able to use adequate contraception until 6 months after the last treatment to prevent pregnancy.

Who Cannot Join the Study?

Patients who have not achieved a Complete Metabolic Response (CMR) after treatment with DA-EPOCH-R. This means the cancer must have responded completely to the initial treatment.
Patients with medical conditions other than Diffuse Large B-Cell Lymphoma.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or are part of a vulnerable population that cannot participate in the study.
Patients who are not eligible for nivolumab consolidation treatment. Nivolumab is a type of medication used in cancer treatment.

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
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Medisch Centrum Leeuwarden B.V.	Leeuwarden	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Flevoziekenhuis Stichting	Almere	The Netherlands
Haga Hospital	Hague	The Netherlands
ZNA Stuivenberg	Antwerp	Belgium
Dijklander Ziekenhuis	Hoorn	The Netherlands
Afhrfauaof Zmtzcbocdl Mrqpeuwkay	Maastricht	The Netherlands
Sjygbdcot Rsnbdun Ucjgweugfb Mmevhde Clxjoy	Nijmegen	The Netherlands
Swi Ewblnnpjd Hnajqwee Trxhliy	Tilburg	The Netherlands
Abpzbvgzt Url	Amsterdam	The Netherlands
Esekvlh Usvickpgvfrw Mtfnxmx Cfytlmi Rlypzlffe (usurfuz Mhy	Rotterdam	The Netherlands
Aulsbuwg Dw Rupxmf Zbujdogtlq Blhi	Goes	The Netherlands
Aaiwkgpft Upe	Amsterdam	The Netherlands
Uzfzkxqmzauv Myjtihf Ccuueii Gfyimesrx	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2022
The Netherlands	Not recruiting	01.07.2022

Trial locations

Investigated drugs:

DA-EPOCH-R is a combination of several chemotherapy drugs used to treat certain types of cancer, including high-grade B cell lymphoma. This treatment is designed to kill cancer cells and stop them from growing and spreading. It is often used as an initial treatment to reduce the size of the tumor and eliminate as many cancer cells as possible.

Nivolumab is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a protein that prevents your immune system from attacking cancer cells. By doing this, nivolumab helps your body recognize and destroy cancer cells more effectively. In this trial, it is used after the initial chemotherapy to help maintain the response and prevent the cancer from coming back.

Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, but it can also occur in other organs. The disease progresses quickly, with symptoms that may include swelling of lymph nodes, fever, night sweats, and weight loss. As it advances, it can spread to other parts of the body, including the bone marrow and central nervous system. The progression can vary, with some cases remaining localized while others become more widespread. The disease is characterized by its aggressive nature, requiring prompt medical attention.

Trial ID:

2022-501038-48-00

Protocol code:

HO152

NCT ID:

NCT03620578

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of DA-EPOCH-R and Nivolumab in Patients with Newly Diagnosed High-Grade B-Cell Lymphoma with MYC and BCL2/BCL6 Rearrangements

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?