Study of Ibrutinib and Obinutuzumab for Patients with Chronic Lymphocytic Leukemia Who Have Not Received Treatment Before

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What is this study about?

This clinical trial is focused on studying a type of cancer called Chronic Lymphocytic Leukemia (CLL), which is a slow-growing blood cancer that affects white blood cells. The study is exploring the use of two medications, Ibrutinib and Obinutuzumab, as a first-line treatment for patients who have not received any prior treatment for CLL. Ibrutinib is taken orally, meaning it is swallowed in pill form, while Obinutuzumab is administered intravenously, which means it is given through a vein.

The purpose of the study is to evaluate the effectiveness of this treatment combination in reducing the presence of cancer cells in the bone marrow. Participants will receive Ibrutinib over a period of 24 cycles, and Obinutuzumab will be given during specific cycles. The study will monitor the patients for 30 days after the completion of the treatment to assess the reduction of cancer cells.

This trial aims to provide valuable information on how well this treatment works for patients with Chronic Lymphocytic Leukemia. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the treatment’s effectiveness. The study will help in understanding whether this combination of medications can be a beneficial option for treating CLL.

1 initiation of treatment

The treatment begins with the administration of ibrutinib and obinutuzumab. These medications are used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Ibrutinib is taken orally, which means it is swallowed in the form of a pill. The dosage and frequency will be determined by the healthcare provider based on individual needs.

2 obinutuzumab administration

Obinutuzumab is administered intravenously, meaning it is given through a vein. This occurs during specific cycles of the treatment.

In Cycle 13, obinutuzumab is given on Days 1, 2, 8, and 15. In Cycles 14 to 18, it is administered on Day 1 of each cycle.

3 ibrutinib administration

Ibrutinib is taken continuously from Cycle 1 to Cycle 24. The exact dosage and schedule will be provided by the healthcare team.

4 follow-up evaluation

After completing the treatment cycles, a follow-up evaluation is conducted 30 days later. This involves assessing the presence of minimal residual disease (MRD) in the bone marrow (BM).

The goal is to determine the percentage of patients with MRD less than 10^-4, which indicates a low level of remaining cancer cells.

Who Can Join the Study?

Must be 18 years or older.
Must have a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL), which are specific types of blood cancer.
The disease must be active and untreated, meaning it needs treatment according to specific guidelines.
Must have an ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
Must have measurable lymph node disease, meaning the lymph nodes are larger than 1.5 cm as seen on a CT scan.
Must have an adequate blood count, which includes:
- Absolute neutrophil count (ANC) greater than 750 cells per microliter.
- Platelet count greater than 30,000 per microliter.
- Hemoglobin level greater than 8.0 grams per deciliter.
Must have adequate liver and kidney function, which includes:
- Liver enzymes (AST or ALT) not more than 3 times the normal limit.
- Creatinine clearance of at least 30 mL per minute, which measures kidney function.
- Bilirubin not more than 1.5 times the normal limit, unless due to a specific condition like Gilbert’s syndrome.
Must have normal blood clotting times, which includes:
- Prothrombin time (PT)/International normal ratio (INR) less than 1.5 times the normal limit.
- Activated partial thromboplastin time (aPTT) less than 1.5 times the normal limit, unless due to a bleeding disorder.

Who Cannot Join the Study?

Patients who have a different type of cancer than chronic lymphocytic leukemia or small lymphocytic lymphoma.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend follow-up visits.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are recovering from a major illness.
Patients who have a history of allergic reactions to the study medications.
Patients who have a history of substance abuse or are currently using illegal drugs.
Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Aurnixz Ouacxwdypkr Odyzdhgd Rpgcgnj Vwqsg Sqcpp Cetpxdxg	Palermo	Italy
Aygtewk Ocobrxvwzek Ublrkyamjzxtf Cgzqidenupcz Dgrgi Sadcsb E Defvj Swxtjae Dl Tlcsku	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	31.03.2021

Trial locations

Investigated drugs:

Ibrutinib

Ibrutinib is a medication used in this trial to treat patients with chronic lymphocytic leukemia (CLL) who have not received treatment before. It works by blocking a specific protein that helps cancer cells grow, which can slow down or stop the progression of the disease.

Obinutuzumab is another medication used in this trial for patients with CLL. It is a type of antibody therapy that targets and attaches to cancer cells, helping the immune system to destroy them. This medication is given in specific cycles as part of the treatment plan.

Investigated diseases:

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells. These cells, called lymphocytes, grow slowly and accumulate over time, interfering with normal blood cell production. As the disease progresses, it can lead to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. The disease often progresses slowly, and some individuals may not experience symptoms for years. Over time, the abnormal cells can spread to other parts of the body, including the liver and spleen.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that is closely related to chronic lymphocytic leukemia, involving the same type of abnormal lymphocytes. Unlike chronic lymphocytic leukemia, which primarily affects the blood and bone marrow, small lymphocytic lymphoma mainly involves the lymph nodes. The disease progresses slowly, often without symptoms in the early stages. As it advances, it can cause swollen lymph nodes, fatigue, and an increased risk of infections. The abnormal lymphocytes can eventually spread to other organs, such as the liver and spleen.

Trial ID:

2024-514824-18-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ibrutinib and Obinutuzumab for Patients with Chronic Lymphocytic Leukemia Who Have Not Received Treatment Before

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?