Study on the Effectiveness and Safety of Ibrutinib with Rituximab-CHOP for Untreated Patients with Diffuse Large B-cell Lymphoma at High Risk

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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 the subtype known as Activated-B-Cell (ABC) DLBCL. The study is investigating the effectiveness and safety of a treatment combination that includes the medication Ibrutinib, which is a Bruton’s tyrosine kinase inhibitor, and a regimen known as Rituximab-CHOP. This regimen consists of several drugs: Rituximab (a monoclonal antibody), Cyclophosphamide (a nitrogen mustard), Doxorubicin (an anthracycline), Vincristine (a Vinka alkaloid), and Prednisone (a corticosteroid). The purpose of the study is to evaluate how well this combination works in patients who have not been treated before and are at intermediate-high and high risk according to a specific scoring system called the International Prognostic Index (IPI).

Participants in the study will first receive the combination of Ibrutinib and Rituximab-CHOP. After this initial treatment phase, they will continue with Ibrutinib alone as a maintenance therapy. The study aims to observe the progression-free survival, which means the length of time during and after the treatment that the patient lives with the disease without it getting worse. Other aspects being monitored include overall survival, the rate of complete response, and any side effects or adverse events that may occur during the treatment.

This trial is designed to provide valuable information on the potential benefits and risks of using Ibrutinib in combination with Rituximab-CHOP for treating patients with ABC-DLBCL. The study will help determine if this treatment approach can improve outcomes for patients with this specific type of lymphoma. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatment.

1 initial treatment phase

Upon joining the study, you will begin the initial treatment phase. This involves receiving a combination of medications designed to treat your condition.

You will take ibrutinib orally. The dosage and frequency will be determined by your healthcare provider based on your specific needs.

You will also receive rituximab, cyclophosphamide, doxorubicin hydrochloride, and vinorelbine through intravenous administration. These medications will be given in a healthcare setting.

Additionally, you will take prednisolone orally as part of your treatment regimen.

2 maintenance phase

After completing the initial treatment phase, you will enter the maintenance phase.

During this phase, you will continue to take ibrutinib orally. The purpose of this phase is to maintain the progress achieved during the initial treatment.

The duration of the maintenance phase will be determined by your healthcare provider, based on your response to the treatment.

3 regular monitoring

Throughout the trial, you will undergo regular monitoring to assess your response to the treatment and to ensure your safety.

This monitoring will include routine blood tests, imaging studies, and other assessments as needed.

Your healthcare team will provide you with specific instructions on when and where these assessments will take place.

4 follow-up

After completing the treatment phases, you will enter a follow-up period.

During this time, your health and progress will continue to be monitored to evaluate the long-term effects of the treatment.

The follow-up period is an important part of the study to ensure your well-being and to gather additional information about the treatment’s effectiveness.

Who Can Join the Study?

Must have a confirmed diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) or related types.
Can have a past or hidden hepatitis B infection if the virus is not currently detectable. Must agree to regular testing and preventive treatment.
No active hepatitis C infection.
Must have biopsy material available for testing.
No disease affecting the central nervous system (brain or spinal cord).
No active infections.
No nerve damage or active brain diseases not related to cancer.
No major surgeries in the last 3 months unless related to lymphoma, and no other life-threatening diseases that could affect treatment.
No other cancers, except for certain skin cancers or cervical cancer that have been treated and are not active for at least 5 years.
Women who can become pregnant and men who are sexually active must use effective birth control during and after the study.
Women who can become pregnant must have a negative pregnancy test before starting the study. Pregnant or breastfeeding women cannot participate.
Must have a specific type of DLBCL confirmed by a test called Lymph2Cx.
Must have a life expectancy of more than 6 months.
Must provide written consent to participate, understanding the study’s purpose and procedures.
Must not have received any previous treatment for the disease.
Must be between 18 and 64 years old.
Must have an IPI score of 2 or higher. (IPI is a score that helps determine the severity of lymphoma.)
Must have Ann Arbor stage II-IV disease, which indicates the extent of lymphoma spread.
Must have a measurable disease size of at least 1.5 cm in the longest dimension.
Must have normal blood counts and organ functions as specified by the study.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, unless it was a type of skin cancer called basal cell carcinoma or a type of cervical cancer called carcinoma in situ, which have been successfully treated.
Patients who have a serious infection that is not controlled or treated.
Patients who have a history of heart problems, such as heart failure or a heart attack.
Patients who have a condition called QT prolongation, which affects the heart’s electrical activity.
Patients who are pregnant or breastfeeding.
Patients who have an allergy to any of the study medications.
Patients who have received another investigational drug within the last 30 days.
Patients who have a condition that affects their ability to absorb medications in the stomach or intestines.
Patients who have a history of bleeding disorders or are taking medications that increase the risk of bleeding.
Patients who have a condition called hepatitis B or C, which are viral infections that affect the liver.
Patients who have HIV, which is a virus that affects the immune system.
Patients who have had a stem cell transplant in the past.
Patients who have a condition called autoimmune disease, where the immune system attacks the body’s own cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Universita Cattolica Del Sacro Cuore	Rome	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Apdplzs Otujrudixvv Rcqoagyaw Sgo Ctyuz	Potenza	Italy
Ozokcasn Gmpbdmnrj	Catania	Italy
Abplang Ozwtvajecus Urptnwpdwxwao Cfkwqlnaglhq Dksyi Sospqg E Djype Skfsaok Dg Tyomvu	Turin	Italy
Awbtaxt Orcnnjraqhr Npnnlabne Sv Aeujfdc E Bqoazt E C Athmcc Anjslhwhrxo	Alexandria	Italy
Apsarmq Urg Ifoeo Dl Rrzrye Ekszwl	Reggio Emilia	Italy
Udzygpbges Dxuvc Sgpxn Dp Reld Lg Szwtrsjj	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.08.2019

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this trial to help treat a type of cancer called Activated-B-Cell Diffuse Large B-Cell Lymphoma (ABC-DLBCL). It works by blocking a specific protein in cancer cells, which can help stop the cancer from growing and spreading. In this study, ibrutinib is used in combination with other treatments to see if it can improve the outcomes for patients who have not been treated before.

Rituximab is a medication that is part of the treatment regimen in this trial. It is an antibody that targets a specific protein on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Rituximab is used in combination with other drugs to enhance the overall effectiveness of the treatment for patients with ABC-DLBCL.

CHOP is a combination of chemotherapy drugs used in this trial. It includes four different medications that work together to kill cancer cells or stop them from growing. CHOP is a standard treatment for certain types of lymphoma, and in this study, it is combined with other therapies to evaluate its effectiveness in treating ABC-DLBCL.

Investigated diseases:

Diffuse large B-cell lymphoma

Diffuse Large B-cell Lymphoma – Diffuse Large B-cell Lymphoma (DLBCL) is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease progresses quickly, often requiring prompt medical attention. As it advances, it can spread to other parts of the body, including the bone marrow and central nervous system. Symptoms may include swelling of lymph nodes, fever, night sweats, and weight loss. The progression of DLBCL can vary, with some cases remaining localized while others become more widespread.

Trial ID:

2024-511641-18-00

Protocol code:

FIL_RI-CHOP

NCT ID:

NCT03731234

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Ibrutinib with Rituximab-CHOP for Untreated Patients with Diffuse Large B-cell Lymphoma at High Risk

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?