Study of Nivolumab and Chemotherapy Combination for Patients with Refractory Hodgkin’s Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Hodgkin’s lymphoma, specifically in patients whose disease has not responded to initial treatment. The study will use a medication called nivolumab, which is given through an infusion into a vein. Nivolumab is a type of treatment that helps the immune system fight cancer cells. After receiving nivolumab, patients will undergo chemotherapy with three drugs: bendamustine, gemcitabine, and dexamethasone. This will be followed by a procedure called autologous bone marrow transplantation, where a patient’s own stem cells are used to help restore their bone marrow.

The purpose of this study is to evaluate how effective and safe this treatment approach is for patients with Hodgkin’s lymphoma that is resistant to previous treatments. The study will also look at the potential of using a blood test to predict how well patients might respond to the treatment. This blood test measures the amount of DNA from Hodgkin’s lymphoma cells circulating in the blood before the bone marrow transplantation.

Participants in the study will first receive nivolumab, followed by two cycles of the chemotherapy combination. Afterward, they will undergo the bone marrow transplantation. The study will monitor the patients to see how well the treatment works and to check for any side effects. The goal is to find out if this treatment can help patients achieve remission, which means the cancer is no longer detectable, and to understand how long patients can live without the disease getting worse.

1 initiation of nivolumab treatment

Receive nivolumab through an intravenous infusion. This is a medication designed to help the immune system fight cancer cells.

The treatment involves three administrations of nivolumab. The exact schedule and dosage will be provided by the healthcare team.

2 chemotherapy with BGD

After completing nivolumab treatment, begin chemotherapy with a combination of bendamustine, gemcitabine, and dexamethasone (BGD).

This phase consists of two cycles of chemotherapy. The healthcare team will provide specific details on the timing and dosage of each medication.

3 autologous bone marrow transplantation

Undergo an autologous bone marrow transplantation, which involves using your own stem cells to help restore bone marrow function after chemotherapy.

This procedure is intended to consolidate the treatment and improve outcomes.

4 monitoring and follow-up

Regular follow-up appointments will be scheduled to monitor health and response to treatment.

Assessments may include imaging tests and blood work to evaluate the effectiveness of the treatment and check for any side effects.

Who Can Join the Study?

Patients must have a recurrence of a type of cancer called classical Hodgkin’s lymphoma. This must be confirmed by a local pathology report according to a specific classification from 2016.
Patients should have been initially diagnosed in certain stages of the disease, such as stage IIA with a large tumor or a massive lesion, or in stages IIB-IV.
Patients with primary refractory classical Hodgkin’s lymphoma must meet specific criteria, such as having a large tumor or a massive lesion, or being in stages IIB-IV.
Primary resistance to treatment is defined by a positive test called iPET2 after the second cycle of first-line chemotherapy. If the iPET2 test is negative, active disease must be confirmed by a PET-CT scan within three months after the first-line chemotherapy.
The advancement of the disease must be evaluated by a PET examination at diagnosis.
Patients must be 18 years or older.
Patients must have an ECOG performance status of 0-2, which is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
There must be at least one measurable change in the patient’s condition.
Patients must agree to use effective contraception during the study. Women must use contraception for 14 months and men for 11 months after the last dose of treatment.
Women of childbearing age must have a negative pregnancy test at the start of the study and agree to use highly effective contraception during the study and for 14 months after the last dose of chemotherapy. This does not apply to women over 50 who have not had a period for at least 12 months or have had certain surgeries.
Patients must sign a consent form to participate in the clinical trial.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Hodgkin’s lymphoma.
Patients who have not shown resistance or relapse after previous treatments for Hodgkin’s lymphoma.
Patients who are not within the specified age range for the study.
Patients who are unable to undergo BGD chemotherapy or autologous transplantation of hematopoietic stem cells. BGD chemotherapy is a specific combination of cancer-fighting drugs, and autologous transplantation of hematopoietic stem cells is a procedure where a patient’s own stem cells are used to help recover from high-dose chemotherapy.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Wztgstlkpbb Wosqyyaalpggaawyxtvl Ciurkif Oscdkzzzp I Tlljzwmpqifsk Id Mmvroqcnfcb W Lksjg	Lodz	Poland
Nzmyqamx Iwdotpky Oiwdlsqsg Ilo Meywo Sdkqwxfpbtnxwgodzzkbdegubufj Ioxgsmvw Bdvufuvb	Cracow	Poland
Uaqbiojazprlfl Ceqlknv Kaskaljix	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.03.2022

Trial locations

Investigated drugs:

Nivolumab

Nivolumab is a medication used in this trial as an early second-line treatment for patients with Hodgkin’s lymphoma who did not respond to their first treatment. It works by helping the immune system recognize and attack cancer cells more effectively.

Bendamustine is part of the chemotherapy regimen used in this trial. It is designed to kill cancer cells and slow down their growth by damaging their DNA.

Gemcitabine is another chemotherapy drug included in the treatment plan. It works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading.

Dexamethasone is a steroid used in combination with other chemotherapy drugs. It helps reduce inflammation and can also help manage some side effects of chemotherapy.

Autologous Hematopoietic Stem Cell Transplantation (aHCT) is a procedure where a patient’s own stem cells are collected, stored, and then given back to them after intensive chemotherapy. This helps restore the bone marrow and allows the body to produce healthy blood cells again.

Hodgkin’s Lymphoma – Hodgkin’s lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body’s 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 Hodgkin’s lymphoma can vary, with some cases responding well to initial treatment, while others may become resistant or relapse. In refractory or relapsed cases, the disease does not respond to standard treatments or returns after a period of remission.

Trial ID:

2024-515064-31-00

Protocol code:

NBK132/2/2021

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nivolumab and Chemotherapy Combination for Patients with Refractory Hodgkin’s Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?