Study on Ibrutinib and Venetoclax for Patients with Untreated 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), which is a condition where the bone marrow makes too many lymphocytes, a type of white blood cell. The study is exploring the use of two treatments: Ibrutinib and Venetoclax. Ibrutinib, also known by its code name JNJ-54179060, is a medication that comes in the form of hard capsules. Venetoclax, also known as ABT-199 or GDC-0199, is available as film-coated tablets in different strengths (10 mg, 50 mg, and 100 mg). These medications are taken orally, meaning they are swallowed.

The purpose of the study is to evaluate how effective these treatments are when used in a customized way for patients who have not been treated for CLL before. The study will compare the effects of using Ibrutinib alone and in combination with Venetoclax, with adjustments made to the dosage based on how patients respond to the treatment. This approach aims to tailor the treatment to each patient’s needs, either by reducing the dose proactively or modifying it in response to any side effects.

Participants in the study will receive either Ibrutinib alone or a combination of Ibrutinib and Venetoclax. The study will monitor the patients over a period to see how well the treatments work and how the patients tolerate them. The goal is to find the best way to use these medications to treat CLL effectively while minimizing side effects. The study will also include a comparison with historical data from previous clinical trials to assess the outcomes of the tailored treatment approach.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Eligibility is based on specific criteria, such as a diagnosis of chronic lymphocytic leukemia (CLL) and adequate organ function.

2 treatment initiation

The treatment phase begins with the administration of medications. The study involves two main treatment regimens: a combination of ibrutinib and venetoclax (I+V), or ibrutinib alone.

For the I+V regimen, ibrutinib is taken orally as a 140 mg hard capsule, and venetoclax is taken orally in varying doses: 10 mg, 50 mg, or 100 mg film-coated tablets.

3 dose adjustment

Dosing of ibrutinib may be adjusted based on individual response and any side effects experienced. This tailored approach aims to optimize treatment effectiveness while minimizing adverse effects.

4 ongoing monitoring

Regular monitoring is conducted throughout the trial to assess the effectiveness of the treatment and to check for any side effects.

This includes routine blood tests and health assessments to ensure the treatment is working as intended and to make any necessary adjustments.

5 completion of treatment

The treatment phase continues until the study’s end date, which is estimated to be November 16, 2028.

Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

Who Can Join the Study?

The patient must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that meets specific diagnostic criteria.
For patients in the I+V treatment group, they must have an ECOG performance status of 0-1. For those in the ibrutinib monotherapy group, the ECOG performance status should be 0-2. The ECOG performance status is a scale used to assess how a disease affects a patient’s daily living abilities, with 0 being fully active and 5 being deceased.
The patient must have active disease that requires treatment, meeting at least one of the following criteria:
- Worsening of anemia (low red blood cells) or thrombocytopenia (low platelets).
- Enlarged or worsening spleen (an organ that helps filter blood).
- Large or worsening lymph nodes (part of the immune system).
- Increasing number of lymphocytes (a type of white blood cell) in the blood.
- Autoimmune complications like anemia or thrombocytopenia that do not respond well to treatment.
- Symptoms or problems in areas outside the lymph nodes, such as the skin, kidneys, lungs, or spine.
- Symptoms related to the disease, such as:
  - Unintentional weight loss of 10% or more in the last 6 months.
  - Significant fatigue, meaning the patient cannot work or perform usual activities.
  - Fevers of 100.5°F (38.0°C) or higher for 2 weeks or more without infection.
  - Night sweats for 1 month or more without infection.
The patient must have adequate blood function without needing transfusions or growth factor support for at least 7 days before screening. This includes:
- ANC (absolute neutrophil count) greater than 750/μL.
- Platelet count greater than 50,000/μL.
- Hemoglobin level greater than 8.0 g/dL.
The patient must have adequate liver function, which means:
- AST or ALT (liver enzymes) levels no more than 3 times the upper limit of normal.
- Bilirubin level no more than 1.5 times the upper limit of normal, unless due to specific conditions.
- Prothrombin time and activated partial thromboplastin time within normal limits, unless due to unrelated conditions.
The patient must have adequate kidney function, defined as:
- For I+V treatment group: Creatinine clearance (CrCl) of at least 45 mL/min for those under 75 years old, and at least 60 mL/min for those 75 years or older.
- For ibrutinib monotherapy group: CrCl of at least 45 mL/min.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients with untreated Chronic Lymphocytic Leukemia cannot participate. This means if you have this type of blood cancer and have not received any treatment for it, you are not eligible.
Patients who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the trial is looking for specific types of participants.
Both male and female patients are eligible, but if you do not identify as either, you may not be eligible.
Patients who are considered part of a vulnerable population cannot participate. This refers to groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Of Pecs	Pecs	Hungary
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
University Hospital Olomouc	Olomouc	Czechia
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Semmelweis University	Budapest	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Institute Of Hematology And Blood Transfusion	Prague	Czechia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
University Of Szeged	Szeged	Hungary
University Hospital Ostrava	Ostrava	Czechia
Gdjudaufiffdamsxa Vxxwwenmu Payt Apztis Eeglpeeh Ozlmei Kufeiy	Gyor	Hungary
Aeikfsl Oaqlrumjdte Odcekmoz Rvqmkcc Vcklf Spadr Czowzdch	Palermo	Italy
Culsjc Hmyvabcybna Uchxugldijmsc Remuk	Reims	France
Untftgnnrd Duwbd Sbnlp Df Rapz Lo Siastqwm	Rome	Italy
Hevnxvqp Uhmmbhpxjiwhx Mpyeexq Do Vkgkqspnyi	Santander	Spain
Uiaorylvhb Hgrrbeekf Ptefp Sbjwxjoggwg Crjmtok Frxk	Paris	France
Wsiwmzmpuew Wmkrolsvmigyagtrwyoh Cxmxnlq Oqvywvazx I Tzkajhaomnmeq If Mfhrcvqrmnm W Lnjdt	Lodz	Poland
Spciwjhd Pfowkgydt Scp z oyay	Gdynia	Poland
Htvdpuvo Vzkq dwkxyhfe	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	28.11.2023
France	Recruiting	28.11.2023
Hungary	Recruiting	28.11.2023
Italy	Recruiting	28.11.2023
Poland	Recruiting	28.11.2023
Spain	Recruiting	28.11.2023

Trial locations

Investigated drugs:

Ibrutinib is a medication used in this study to treat patients with chronic lymphocytic leukemia who have not been treated before. It works by blocking a specific protein that helps cancer cells grow and survive. The study aims to find the best way to use ibrutinib by adjusting the dose based on how patients respond to the treatment or any side effects they experience.

I+V refers to a combination treatment involving ibrutinib and another medication. This combination is being tested to see if it is more effective than using ibrutinib alone. The study will compare the results of this combination treatment to past studies where only ibrutinib was used.

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, accumulate over time and can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, it can cause anemia, bleeding problems, and increased risk of infections. The progression of the disease varies among individuals, with some experiencing a more aggressive form. Chronic lymphocytic leukemia is more common in older adults and is considered a rare disease.

Trial ID:

2023-504044-34-00

Protocol code:

54179060CLL2032

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ibrutinib and Venetoclax for Patients with Untreated Chronic Lymphocytic Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?