Study on Obinutuzumab, Venetoclax, and Ibrutinib for Patients with Relapsed or Refractory 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, which can be challenging to treat, especially when it returns or does not respond to previous treatments. The study is testing a combination of three medications: Obinutuzumab, Venetoclax (also known by its code name GDC-0199), and Ibrutinib. These medications are being used together to see if they can help patients with this type of lymphoma.

The purpose of the study is to evaluate the safety and effectiveness of these medications when used in combination. The study is divided into different steps. Initially, the safety of using Obinutuzumab and Ibrutinib together is assessed. If this combination is safe, the study then explores adding Venetoclax to the mix. The final step involves confirming the safety of all three medications used together. Throughout the study, participants will receive these medications in specific doses, and their health will be closely monitored to ensure their safety.

Participants in the study will receive the medications in different forms: Obinutuzumab as a concentrate for infusion, Venetoclax as a tablet, and Ibrutinib as a capsule. The study aims to find the best dose of these medications that can be tolerated by patients while also being effective in treating Mantle Cell Lymphoma. The study will continue until the researchers gather enough information to understand how well these medications work together and how safe they are for patients.

1 Step A: Initial Treatment

In this step, the focus is on evaluating the safety of the combination of obinutuzumab and ibrutinib. You will receive a fixed dose of 560 mg of ibrutinib daily, taken orally, and 1000 mg of obinutuzumab as an infusion.

The primary goal is to monitor for any unacceptable side effects during the first cycle of treatment. This step is specifically for patients with relapsed or refractory mantle cell lymphoma.

2 Step B: Dose Determination

This step begins if no unacceptable side effects are observed in Step A. The aim is to determine the maximum tolerated dose of venetoclax (also known as GDC-0199) in addition to the combination of obinutuzumab and ibrutinib.

You will continue to receive 560 mg of ibrutinib daily and 1000 mg of obinutuzumab. The dose of venetoclax will be adjusted, starting at 400 mg per day, taken orally. This step is for patients with relapsed or refractory mantle cell lymphoma.

3 Step C: Safety Confirmation

This step is conducted if no unacceptable side effects are observed during Step B. The objective is to confirm the safety of the combination of obinutuzumab, ibrutinib, and venetoclax at fixed doses.

You will receive 560 mg of ibrutinib daily, 1000 mg of obinutuzumab, and 400 mg of venetoclax daily. This step is for patients with untreated mantle cell lymphoma.

Who Can Join the Study?

Must be at least 18 years old for French patients and 16 years old for English patients.
Women who can have children and men who are sexually active must use a highly effective method of birth control during and after the study. Men must agree not to donate sperm during and after the study. For women, these rules apply for at least 30 days after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer. For men, these rules apply for 6 months after the last dose of the study drug.
Women who can have children must have a negative pregnancy test at the start of the study. Women who are pregnant or breastfeeding cannot participate.
Must provide a written signed consent form agreeing to participate in the study.
For Steps A and B: Must have relapsed or refractory disease after at least one line of treatment. The relapse diagnosis must be confirmed by a tumor biopsy or the presence of circulating tumor cells in the blood or bone marrow.
For Step C: Must be untreated with a confirmed diagnosis of mantle cell lymphoma.
Must be at Stage II-IV and in need of treatment.
Must have an ECOG performance status of 0 to 2, which measures daily living abilities.
Blood values must be within certain limits: Absolute neutrophil count (a type of white blood cell) must be at least 1000/mm³, and platelets (cells that help with blood clotting) must be at least 75,000/mm³ or 50,000/mm³ if there is bone marrow involvement.
Certain biochemical values must be within limits: ALT and AST (liver enzymes) must be no more than 3 times the upper limit of normal, total bilirubin must be no more than 1.5 times the upper limit unless due to Gilbert’s syndrome or non-liver causes, and serum creatinine must be no more than 2 times the upper limit or an estimated Glomerular Filtration Rate of at least 50 mL/min/1.73m².
Must test negative for HIV, anti-HBc, and HbsAg.
Must have a life expectancy of more than 3 months.

Who Cannot Join the Study?

Patients who do not have relapsed or refractory Mantle Cell Lymphoma. Relapsed means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might 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
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France
Ccvwyc Hganablabbp Ueumaiwdkkbmc Dt Dsese	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.10.2015

Trial locations

Investigated drugs:

Obinutuzumab is a type of medication known as a monoclonal antibody. It works by targeting specific cells in the immune system, helping the body to fight against certain types of cancer, like Mantle Cell Lymphoma. In this trial, it is used in combination with other medications to see if it can help improve treatment outcomes for patients whose cancer has returned or is not responding to previous treatments.

Ibrutinib is a medication that helps to block certain proteins that cancer cells need to grow and spread. By interfering with these proteins, Ibrutinib can help slow down or stop the growth of cancer cells. It is used in this trial to see if it can work effectively with other medications to treat Mantle Cell Lymphoma that has come back or is resistant to other treatments.

GDC-0199, also known as ABT-199, is a medication that targets and blocks a protein that helps cancer cells survive. By blocking this protein, GDC-0199 can help to kill cancer cells and reduce the size of tumors. In this trial, it is being tested in combination with other medications to determine the best dose and to see if it can safely and effectively treat patients with Mantle Cell Lymphoma.

Investigated diseases:

Mantle cell lymphoma

Mantle Cell Lymphoma – Mantle Cell Lymphoma 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. The disease is characterized by the abnormal growth of these B-cells, which can form tumors in the lymph nodes and spread to other parts of the body, including the bone marrow, spleen, and gastrointestinal tract. As the disease progresses, it can lead to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing rapidly while others may progress more slowly.

Trial ID:

2024-516750-21-00

Protocol code:

RC14_0048

NCT ID:

NCT02558816

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Obinutuzumab, Venetoclax, and Ibrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma

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