Study on Acalabrutinib, Venetoclax, and Obinutuzumab for Untreated Chronic Lymphocytic Leukemia Patients Without del(17p) or TP53 Mutation

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment approach for people with Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study involves a combination of medications, including an investigational drug called acalabrutinib (also known as ACP-196), and two other drugs, venetoclax and obinutuzumab. These medications will be compared to standard chemotherapy treatments that are commonly used for CLL, such as combinations involving fludarabine, cyclophosphamide, and rituximab, or bendamustine and rituximab.

The purpose of this study is to evaluate how well the new combination of acalabrutinib, venetoclax, and obinutuzumab works compared to the traditional chemotherapy options. Participants in the study will be randomly assigned to receive either the new combination treatment or one of the standard chemotherapy treatments. The study will monitor participants over a period of time to assess the progression of the disease and any side effects experienced. The medications will be administered either orally or through intravenous infusion, depending on the specific drug.

This trial is designed for individuals who have not received prior treatment for their CLL and do not have certain genetic mutations, specifically the del(17p) or TP53 mutation. The study aims to provide valuable information on whether the new treatment combination can offer better outcomes for patients with CLL compared to existing chemotherapy options. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.

1 randomization

Upon joining the study, participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatment options being tested.

2 treatment group assignment

Participants are assigned to one of the following treatment groups:

Arm A: Acalabrutinib and Venetoclax, with or without Obinutuzumab.

Arm C: Chemoimmunotherapy, which includes Fludarabine, Cyclophosphamide, and Rituximab (FCR) or Bendamustine and Rituximab (BR).

3 treatment administration

Participants in Arm A receive Acalabrutinib and Venetoclax orally. Obinutuzumab is administered intravenously if included.

Participants in Arm C receive Fludarabine, Cyclophosphamide, and Rituximab or Bendamustine and Rituximab intravenously.

4 treatment duration

The duration of treatment varies depending on the specific protocol for each arm. Participants will be informed of the exact schedule and duration of their treatment regimen.

5 monitoring and assessments

Throughout the trial, participants undergo regular monitoring and assessments to evaluate the effectiveness and safety of the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

6 end of treatment

Upon completion of the treatment phase, participants will have a final assessment to determine the outcome of the treatment and any potential side effects.

7 follow-up

Participants may be required to attend follow-up visits to monitor their health status and any long-term effects of the treatment.

Who Can Join the Study?

  • Men and women who are 18 years or older.
  • Have an ECOG performance status of 0 to 2. This is a scale that measures how well a person can perform daily activities.
  • Have a diagnosis of Chronic Lymphocytic Leukemia (CLL) that meets specific criteria. This includes having certain types of B-cells in the blood.
  • Have active disease that requires treatment according to specific guidelines.
  • Meet certain laboratory parameters:
    • Have adequate bone marrow function without needing extra support like growth factors or transfusions. This includes having a certain number of white blood cells and platelets.
    • Have levels of liver enzymes (AST and ALT) that are not more than 2.5 times the normal limit.
    • Have a total bilirubin level that is not more than 2 times the normal limit, unless it is due to a condition called Gilbert’s syndrome.
    • Have an estimated creatinine clearance of at least 50 mL/min. This is a measure of how well the kidneys are working.

Who Cannot Join the Study?

  • Patients who have already received treatment for their Chronic Lymphocytic Leukemia cannot participate. Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients with a specific genetic change called del(17p) or a TP53 Mutation are not eligible. These are changes in the DNA that can affect how the disease behaves.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Hopital Necker Enfants Malades Paris France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Region Oerebro Laen Orebro Sweden
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Hospital Universitario Infanta Leonor Madrid Spain
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Hristo Botev AD Vratsa Bulgaria
Flevoziekenhuis Stichting Almere The Netherlands
Haematologisch Onkologische Schwerpunktpraxis Wuerzburg Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Fakultni Nemocnice Plzen Plzen Czechia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Centre Henri Becquerel Rouen France
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
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
Semmelweis University Budapest Hungary
Narodny Onkologicky Ustav Bratislava Slovakia
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Centre Hospitalier Universitaire De Montpellier Montpellier France
Pratia S.A. Skorzewo Poland
In Vivo Sp. z o.o. Bydgoszcz Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Centre Hospitalier Universitaire De Rennes Rennes France
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hopital Beaujon Clichy France
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Ramrzdzbf Zjibzpzpsr Sqrhqxxih Arnhem The Netherlands
Hcoyokwm Ummvkzjqqwvkr Mcbhifx Do Vyfeqqrrnl Santander Spain
Wvcuzorwwge Wtswvrmiskqrccjhgngq Ckmztch Oleicnugs I Thmzgxbnpojas Iq Mfypssewgdj W Lvpoe Lodz Poland
Srdixsyp Pryiykdeq Sox z ozfa Gdynia Poland
Ujtsiltlqc Hugwxhae Clqhhlh Cologne Germany
Ibekgkxn Rvugcqwuv Pep Lx Sccvvu Dgh Tluinf Dzfq Azyigyp Ielt Skyozn Meldola Italy
Arbsxpfcr Uxl Amsterdam The Netherlands
Uurninj Utfuwknmdr Hurwodhy Uppsala Sweden
Anfrtj Uubzctbkkj Hmjxllmq Aarhus Denmark
Ajjyjym Olfaclulmdo Umicmofkkmuei Citvfxffzlar Djmkf Sipujq E Dnedm Sxxrltl Dk Tswqlr Turin Italy
Hxfxhhfa Dl Li Sumod Cvvb I Smib Pwy Barcelona Spain
Imowarsa Cpskzw Dxeflioxcqclcieio L'hospitalet De Llobregat Spain
Hyzqhtjx Vrss ddoqlaci Barcelona Spain

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
17.05.2024
Bulgaria Bulgaria
Not recruiting
17.05.2024
Czechia Czechia
Not recruiting
17.05.2024
Denmark Denmark
Not recruiting
17.05.2024
France France
Not recruiting
17.05.2024
Germany Germany
Not recruiting
17.05.2024
Hungary Hungary
Not recruiting
17.05.2024
Italy Italy
Not recruiting
17.05.2024
Poland Poland
Not recruiting
17.05.2024
Slovakia Slovakia
Not recruiting
17.05.2024
Spain Spain
Not recruiting
17.05.2024
Sweden Sweden
Not recruiting
17.05.2024
The Netherlands The Netherlands
Not recruiting
17.05.2024

Trial locations

Acalabrutinib: This medication is used to treat certain types of blood cancers, including chronic lymphocytic leukemia. It works by blocking a specific protein in cancer cells, which helps to stop their growth and spread.

Venetoclax: This is a medication that targets and blocks a protein that helps cancer cells survive. By inhibiting this protein, venetoclax can help to kill cancer cells and slow down the progression of the disease.

Obinutuzumab: This is a type of therapy known as a monoclonal antibody. It works by attaching to specific proteins on the surface of cancer cells, marking them for destruction by the immune system.

Fludarabine: This medication is a type of chemotherapy used to treat certain blood cancers. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Cyclophosphamide: This is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is often used in combination with other medications to treat various types of cancer.

Rituximab: This is a monoclonal antibody used to treat certain types of blood cancers. It works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy them.

Bendamustine: This is a chemotherapy medication used to treat certain types of cancer, including chronic lymphocytic leukemia. It works by damaging the DNA in cancer cells, which helps to stop their growth and division.

Investigated diseases:

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal lymphocytes, a type of white blood cell. 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, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. CLL without del(17p) or TP53 mutation refers to a subtype where specific genetic abnormalities are not present, which can influence the disease’s behavior and response to treatment.

Trial ID:
2023-509349-11-00
Protocol code:
ACE-CL-311 (AMPLIFY)
NCT ID:
NCT03836261
Trial Phase:
Therapeutic confirmatory (Phase III)

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