Study Comparing Rituximab with Ibrutinib to Rituximab with Chemotherapy for Older Patients with Untreated Mantle Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma (MCL), which is a rare form of non-Hodgkin’s lymphoma. The study aims to compare two different treatment approaches for older patients who have not yet received treatment for MCL. One group of patients will receive a combination of Rituximab and Ibrutinib, while the other group will receive Rituximab along with various chemotherapy drugs. The chemotherapy drugs being studied include Prednisolone, Cyclophosphamide, Vincristine Sulfate, Bendamustine Hydrochloride, and Doxorubicin Hydrochloride. The purpose of the study is to determine which treatment is more effective in preventing the cancer from getting worse.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will be conducted over a period of time, with regular check-ups and assessments to monitor the progress of the disease and the patient’s response to the treatment. The main focus will be on how long patients can live without the disease getting worse, which is known as progression-free survival. Other aspects such as overall survival, disease response, safety, and quality of life will also be evaluated.

This study is designed to provide valuable information on the best treatment options for older patients with untreated Mantle Cell Lymphoma. By comparing the effectiveness of Rituximab with Ibrutinib against Rituximab with chemotherapy, researchers hope to find a treatment that offers better outcomes for patients. The study will continue until the end of 2026, with the goal of improving the understanding and management of this challenging disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney function, and cardiac health.

Consent is required to participate, and the condition of mantle cell lymphoma (MCL) must be confirmed.

2 randomization

Participants are randomly assigned to one of two treatment groups: Rituximab/Ibrutinib or Rituximab/Chemotherapy.

3 treatment phase

For those in the Rituximab/Ibrutinib group, Ibrutinib is administered orally in the form of 140 mg hard capsules.

For those in the Rituximab/Chemotherapy group, treatment includes a combination of drugs administered intravenously: Prednisolone, Cyclophosphamide, Vincristine Sulfate, Bendamustine Hydrochloride, and Doxorubicin Hydrochloride.

4 monitoring and assessments

Progression-free survival is monitored, which is the time from randomization until disease progression or death.

Overall survival is tracked from randomization until death from any cause.

Disease response is assessed using CT scans and bone marrow biopsies, following standardized criteria.

Safety and side effects are evaluated based on adverse events.

Quality of life is measured using a specific questionnaire.

5 end of study

The study is estimated to conclude by December 31, 2026.

The time to the next MCL treatment is recorded, which is the period from randomization to the start of the next treatment or death.

Who Can Join the Study?

Patients must be male or female and 60 years or older.
Must have a calculated creatinine clearance greater than 30 mL/min. This is a measure of kidney function.
Heart function must be good enough to handle certain chemotherapy treatments, specifically Rituximab-CHOP or Rituximab-Bendamustine.
Must be able to provide voluntary written informed consent, meaning they understand the study and agree to participate.
Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL), with specific characteristics in the cancer cells.
The disease must be at Stage II-IV, which means it is more advanced, and it must be measurable by imaging tests, with a size greater than 1.5 cm.
Should not have received previous treatment for MCL, except for localized radiotherapy or a short course of steroids for symptom relief.
Must be willing and able to take medication to prevent a specific type of pneumonia called Pneumocystis jiroveci Pneumonia.
Must have a performance status of ECOG 0-2, which is a scale that measures how well a patient can perform daily activities.
Must have an absolute neutrophil count greater than 1.0×10^9/L and platelets greater than 100×10^9/L, which are measures of certain blood cells.
AST and/or ALT levels must be less than 3 times the upper limit of normal (ULN). These are liver enzymes.
Total bilirubin must be 1.5 times the ULN or less, unless the increase is due to a condition called Gilbert’s syndrome or another non-liver-related cause.

Who Cannot Join the Study?

Patients who do not have Mantle Cell Lymphoma (MCL) cannot participate. MCL is a type of cancer that affects the lymph nodes.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Vaesterbotten	Umea	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Region Skane	Malmo	Sweden
Region Norrbotten	Lulea	Sweden
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Pirkanmaan hyvinvointialue	Tampere	Finland
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
Region Sjaelland	Holbæk	Denmark
Utwtpib Uwsepdylmt Hialohkk	Uppsala	Sweden
Hktudoxg Uzgtzlsrfx Ctakvkw Hvpaqjex	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	06.12.2017
Finland	Not recruiting	06.12.2017
Norway	Not recruiting	06.12.2017
Sweden	Not recruiting	06.12.2017

Trial locations

Investigated drugs:

Rituximab is a medication used to treat certain types of cancer, including mantle cell lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to destroy them.

Ibrutinib is a medication that helps to stop the growth and spread of cancer cells. It is used in the treatment of mantle cell lymphoma by blocking certain enzymes that cancer cells need to grow.

Chemotherapy refers to a group of cancer treatments that use powerful drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used in combination with other medications to treat mantle cell lymphoma.

Investigated diseases:

Mantle cell lymphoma

Mantle Cell Lymphoma – Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin’s lymphoma, which is a cancer that originates in the lymphatic system. It specifically affects B-cells, a type of white blood cell that plays a crucial role in the immune response. MCL is characterized by the abnormal growth of these B-cells, which can lead to the formation of tumors in lymph nodes and other tissues. The disease often progresses by spreading to other parts of the body, including the bone marrow and gastrointestinal tract. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of MCL can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-514275-18-00

Protocol code:

PenCTU: 10239

Trial Phase:

Therapeutic use (Phase IV)

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Study Comparing Rituximab with Ibrutinib to Rituximab with Chemotherapy for Older Patients with Untreated Mantle Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?