Study Comparing Obinutuzumab and Venetoclax with Obinutuzumab and Chlorambucil for Untreated Chronic Lymphocytic Leukemia Patients with Other Health Conditions

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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). The study is comparing the effectiveness and safety of two different treatment combinations for patients who have not received treatment for CLL before and have other medical conditions. The first treatment combination includes Obinutuzumab and Venetoclax, while the second combination includes Obinutuzumab and Chlorambucil. Obinutuzumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein, while Venetoclax and Chlorambucil are taken as tablets.

The purpose of the study is to determine which treatment combination is more effective in preventing the progression of CLL. Participants in the study will receive one of the two treatment combinations. The study will monitor the participants over a period to see how well the treatments work in controlling the disease and to observe any side effects. The study will also look at how long the treatments can keep the disease from getting worse and how they affect the overall health and survival of the participants.

Throughout the study, participants will have regular check-ups and tests to assess their health and the status of their CLL. These tests will help the researchers understand how the treatments are working and ensure the safety of the participants. The study aims to provide valuable information that could improve treatment options for people with CLL in the future.

1 initial treatment phase

The treatment begins with the administration of obinutuzumab through an intravenous infusion. This is a solution for infusion and is given to help manage chronic lymphocytic leukemia (CLL).

During this phase, rasburicase may also be administered intravenously to help manage uric acid levels in the blood.

2 oral medication phase

Following the initial infusions, venetoclax is introduced. This medication is taken orally in the form of film-coated tablets. The dosage and frequency will be determined by the healthcare provider based on individual patient needs.

In some cases, chlorambucil tablets may be prescribed as an alternative to venetoclax. This is also an oral medication and will be taken according to the schedule provided by the healthcare provider.

3 combination treatment phase

The treatment continues with a combination of obinutuzumab and either venetoclax or chlorambucil. This phase aims to enhance the effectiveness of the treatment by using both intravenous and oral medications.

The duration of this phase and the specific regimen will be tailored to the patient’s response to the treatment and overall health condition.

4 monitoring and assessment

Throughout the trial, regular monitoring will be conducted to assess the patient’s response to the treatment. This includes evaluating progression-free survival, which measures the time during and after treatment that the patient lives with the disease without it getting worse.

Additional assessments may include checking for minimal residual disease (MRD) in the blood and bone marrow, as well as monitoring for any adverse events or side effects.

5 completion of treatment

At the end of the treatment period, a final assessment will be conducted to determine the overall response to the treatment. This includes evaluating the complete response rate and overall survival.

The healthcare provider will discuss the results and any further steps that may be necessary based on the patient’s condition and response to the treatment.

Who Can Join the Study?

  • The patient must have a documented case of Chronic Lymphocytic Leukemia (CLL) that has not been treated before. CLL is a type of cancer that affects the blood and bone marrow.
  • The CLL must require treatment based on specific guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL).
  • The patient must have a Total Cumulative Illness Rating Scale (CIRS) score greater than 6. This scale measures the overall health condition of a person, considering other illnesses they might have.
  • The patient must have a creatinine clearance (CrCl) of less than 70 mL/min. Creatinine clearance is a test that measures how well the kidneys are working.
  • The patient must have adequate bone marrow function without needing support from growth factors or blood transfusions within 2 weeks before the screening, unless the low blood cell count is due to CLL affecting the bone marrow.
  • The patient must have adequate liver function, meaning the liver is working well enough.
  • The patient must have a life expectancy of more than 6 months.
  • Both male and female patients are eligible to participate.

Who Cannot Join the Study?

  • Patients who have received previous treatment for Chronic Lymphocytic Leukemia (CLL). This means if you have already been treated for CLL, you cannot participate.
  • Patients with other serious medical conditions that might interfere with the study. This means if you have other health issues that could affect the study results, you may not be eligible.
  • Patients who are pregnant or breastfeeding. This means if you are expecting a baby or nursing, you cannot join the study.
  • Patients who are unable to follow the study procedures. This means if you cannot comply with the study requirements, you may not be able to participate.
  • Patients with a history of severe allergic reactions to the study drugs. This means if you have had serious allergies to the medications being tested, you cannot take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Institut Gustave Roussy Villejuif France
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Centre Henri Becquerel Rouen France
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Sjællands Universitetshospital Roskilde Denmark
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Vinzenz Von Paul Kliniken gGmbH Stuttgart Germany
KBC Zagreb Zagreb Croatia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Tartu University Hospital Tartu Estonia
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
Spitalul Clinic Judetean Mures Targu Mures Romania
Hospital Universitario De Canarias La Laguna Spain
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Kliniken Maria Hilf GmbH Moenchengladbach Moenchengladbach Germany
Azienda Ospedaliera S Maria Di Terni Terni Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Klinikum Frankfurt (Oder) GmbH Frankfurt (oder) Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Universita’ Degli Studi Di Ferrara Ferrara Italy
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Mutlangen Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Hristo Botev AD Vratsa Bulgaria
Clinique Victor Hugo Le Mans France
Centre Hospitalier Universitaire De Caen Normandie Caen France
North Estonia Medical Centre Foundation Tallin Estonia
Hôpital Pontchaillou-CHU Rennes Rennes France
Fundeni Clinical Institute Bucharest Romania
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Cperzpqz Hcxapaok Doxezph Zagreb Croatia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.02.2015
Bulgaria Bulgaria
Not recruiting
01.02.2015
Croatia Croatia
Not recruiting
01.02.2015
Denmark Denmark
Not recruiting
01.02.2015
Estonia Estonia
Not recruiting
01.02.2015
France France
Not recruiting
01.02.2015
Germany Germany
Not recruiting
01.02.2015
Italy Italy
Not recruiting
01.02.2015
Poland Poland
Not recruiting
01.02.2015
Romania Romania
Not recruiting
01.02.2015
Spain Spain
Not recruiting
01.02.2015

Trial locations

Obinutuzumab is a medication used in the treatment of certain types of blood cancers, including chronic lymphocytic leukemia (CLL). It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy these cells.

Venetoclax is a medication that helps treat chronic lymphocytic leukemia (CLL) by blocking a protein that cancer cells need to survive. This action helps to kill and reduce the number of cancer cells in the body.

Chlorambucil is a chemotherapy drug used to treat chronic lymphocytic leukemia (CLL). It works by slowing or stopping the growth of cancer cells, helping to control the disease.

Investigated diseases:

Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL typically progresses slowly, and many individuals may not experience symptoms for years. As the disease advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:
2023-504034-22-00
Protocol code:
BO25323
Trial Phase:
Therapeutic confirmatory (Phase III)

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