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Study on Ibrutinib and Venetoclax for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Chronic Lymphocytic Leukemia (CLL), specifically in patients whose disease has returned or not responded to previous treatments. The study is testing a combination of two medications: Ibrutinib and Venetoclax. These medications are taken as tablets and work by targeting specific proteins in cancer cells to help stop their growth.

The purpose of the study is to evaluate how effective the combination of Ibrutinib and Venetoclax is in reducing the number of cancer cells to very low levels, a state known as minimal residual disease (MRD) negativity. This means that the cancer cells are reduced to such a low number that they are almost undetectable. The study will follow a specific plan where patients will receive these medications and be monitored to see how well the treatment works over time.

Participants in the study will take the medications as directed and will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide more information on how well this combination of medications can help patients with relapsed or refractory CLL. The trial is open-label, meaning both the researchers and participants know which treatment is being given, and it is not controlled by a placebo group.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the effectiveness of adding ibrutinib to venetoclax for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

The patient will be required to provide consent to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility, which includes documented CLL requiring treatment and adequate bone marrow function.

Tests will be conducted to ensure the patient meets the inclusion criteria, such as a specific neutrophil count and platelet levels.

3 treatment initiation

The patient will begin treatment with venetoclax, which is administered orally.

The dosage and frequency of venetoclax will be determined by the study protocol and adjusted based on the patient’s response and tolerance.

4 addition of ibrutinib

After a specified period, ibrutinib will be added to the treatment regimen.

The combination of ibrutinib and venetoclax aims to achieve minimal residual disease (MRD) negativity, which will be monitored throughout the treatment.

5 monitoring and evaluation

The patient’s response to the treatment will be regularly monitored using multi-colour flow cytometry analysis to evaluate MRD negativity.

Adjustments to the treatment may be made based on the patient’s progress and any side effects experienced.

6 completion of treatment

The treatment period is expected to continue until the estimated end date of January 31, 2025, unless the patient withdraws or the study is concluded earlier.

Upon completion, the patient’s overall response to the treatment will be assessed, and further recommendations will be provided.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) that needs treatment. CLL is a type of cancer that affects the blood and bone marrow.
  • The patient must have relapsed or refractory CLL, meaning the cancer has returned after treatment or did not respond to previous treatments. They must have received at least one prior therapy.
  • The patient must have adequate bone marrow function. Bone marrow is the soft tissue inside bones where blood cells are made. This means:
    • An absolute neutrophil count (ANC) of at least 1.0 x 109/L. Neutrophils are a type of white blood cell important for fighting infections. Growth factors, which help increase blood cell counts, are allowed.
    • Platelets count of at least 30 x 109/L. Platelets help with blood clotting. If low platelet count is due to bone marrow involvement, it should be at least 20 x 109/L.
    • Hemoglobin level of at least 8.0 g/dl. Hemoglobin is a protein in red blood cells that carries oxygen throughout the body.
  • The patient must be within the age range of 18 to 65 years old.
  • Both male and female patients are eligible to participate.
  • The patient should not belong to a vulnerable population, which means they should be able to give informed consent and understand the study requirements.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Azienda Ulss 3 Serenissima Venice Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
08.11.2017

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this trial to treat patients with chronic lymphocytic leukemia (CLL) who have not responded to previous treatments or whose cancer has returned. It works by blocking a specific protein that helps cancer cells grow and survive, thereby slowing down or stopping the progression of the disease.

Venetoclax is another medication used in the trial for patients with CLL. It targets and blocks a protein that prevents cancer cells from dying, which helps to eliminate these cells from the body. The trial aims to assess how well venetoclax works when combined with ibrutinib, using a strategy guided by the level of cancer cells remaining in the body.

Investigated diseases:

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal white blood cells called lymphocytes. These abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. Over time, CLL can become more aggressive, especially in cases that are relapsed or refractory, meaning they do not respond to standard treatments or return after treatment. The disease is more common in older adults and may require ongoing monitoring and management.

Trial ID:
2024-514686-19-00
Trial Phase:
Therapeutic exploratory (Phase II)

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