Study on Lisaftoclax and Acalabrutinib for Patients with Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying the effectiveness of a new treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). The study involves two medications: Lisaftoclax, also known by its code name APG-2575, and Acalabrutinib, marketed as Calquence. Lisaftoclax is a small molecule that targets a protein called Bcl-2, which helps cancer cells survive. Acalabrutinib is a targeted treatment that inhibits a specific enzyme known as Bruton’s tyrosine kinase, which plays a role in the growth of cancer cells.

The purpose of the study is to compare the combination of Lisaftoclax and Acalabrutinib with Acalabrutinib alone in patients who have previously been treated for CLL or SLL. Participants will receive either the combination treatment or Acalabrutinib alone. The study will monitor the progression of the disease and assess the safety and effectiveness of the treatments over a period of time. The trial will also include a placebo group to help understand the effects of the treatments better.

Participants will take the medications orally, in the form of tablets or capsules, for a maximum period of 76 weeks. Throughout the study, regular check-ups and assessments will be conducted to monitor the participants’ health and the progression of their disease. The study aims to provide valuable information on whether the combination of Lisaftoclax and Acalabrutinib offers better outcomes for patients with CLL or SLL compared to Acalabrutinib alone.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatment history, and health status.

Written informed consent is required to participate in the study.

2 randomization

Participants are randomly assigned to one of two groups: one receiving lisaftoclax in combination with acalabrutinib, and the other receiving acalabrutinib alone.

This process ensures that the study results are unbiased.

3 treatment administration

Participants in the combination group take lisaftoclax tablets and acalabrutinib capsules or tablets orally.

Participants in the monotherapy group take acalabrutinib capsules or tablets orally.

The dosage and frequency of administration are determined by the study protocol and are monitored by the study team.

4 monitoring and assessments

Regular assessments are conducted to monitor health status, including blood tests and imaging studies.

The study team evaluates the progression of the disease and any side effects experienced.

5 completion of treatment

The treatment phase continues until disease progression, unacceptable side effects, or completion of the study period.

Participants are monitored for a period after treatment to assess long-term effects and outcomes.

6 follow-up

After completing the treatment phase, follow-up visits are scheduled to monitor overall health and any long-term effects of the treatment.

These visits may include additional tests and assessments as required by the study protocol.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and meet specific treatment guidelines.
  • Must have been treated with acalabrutinib alone for at least 12 months and have a stable disease or partial response with certain risk factors.
  • Must have an ECOG performance status of 0 to 2, which is a scale used to assess how a disease affects a patient’s daily living abilities.
  • Must have adequate bone marrow function, meaning the bone marrow is working well enough to produce blood cells without help from medications or transfusions.
  • Must have adequate kidney function, which means the kidneys are working well enough to filter waste from the blood.
  • Must have adequate liver function, meaning the liver is working well enough to process substances in the body.
  • Must be able and willing to provide written consent and follow the study’s schedule and requirements.

Who Cannot Join the Study?

  • Patients who have not been previously treated with acalabrutinib cannot participate.
  • Patients with medical conditions other than Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Ospedale Vito Fazzi Lecce Lecce Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
MBAL Sveta Marina EAD Varna Bulgaria
Univerzitna Nemocnica Martin Martin Slovakia
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Sana Klinikum Offenbach GmbH Offenbach Am Main Germany
Onkozentrum Dresden Freiberg Meissen Dresden Germany
Azienda Ospedaliera di Padova Padua Italy
University Of Debrecen Debrecen Hungary
Spitalul Clinic Municipal De Urgenta Timisoara Timisoara Romania
Centre Hospitalier Universitaire d’Orléans Orléans France
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Centre Hospitalier Le Mans Le Mans France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Hospital Son Llatzer Palma Spain
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
In Vivo Sp. z o.o. Bydgoszcz Poland
Hopital NOVO Pontoise France
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
CHU Helora La Louviere Belgium
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Servei De Salut De Les Illes Balears Palma Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
L’Hopital Prive Du Confluent Nantes France
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Fundeni Clinical Institute Bucharest Romania
Nquvuaqy Oqputnrt Imdahvfuw Bratislava Slovakia
Cygfwa Lryd Btlmlj Lyon France
Hofjumnl Utdhaelidlijh Dg Lo Pdrscbia Madrid Spain
Hvdmlfam Uctpsqwnbfrxb Muwfats Du Vepentvznw Santander Spain
Wwcsdgsicyw Wxkvmcwblbyrbiiazlma Cpgodar Okmfafrby I Tcpdulanbceeb Ir Mojrpveyslb W Lctvj Lodz Poland
Mcmzmci Caqwle Pdobvuhpqoy Lviy Sofia Bulgaria
Ciwwyh dt Rbtfibyviriyd &bctbdh Ccgfwnxc Srloxx Ajmo STRASBOURG, Alsace France
Anpwywf Sux z oknb Poznan Poland
Imnfzbkk Rnixdnphx Pah Lt Sdrxkl Dmu Tpuysh Dhum Afvhpzu Iyjc Spltll Meldola Italy
Cajrwi Hpsgwncvgfs Rmzsgsro Upmvjopzyprod Dr Tjarh Tours France
Aekedjs Osdtsiulrja Uksfccziuzazp Cstiljfrgyrm Dcutn Sgkrqq E Duraa Syhpioj Dw Tjsehy Turin Italy
Krzalxyz dql Umbwnuhaqmus Mexqijvh Azm Munich Germany
Ammeysz Urg Iyvit Dr Rtmobh Estndh Reggio Emilia Italy
Hpilboeh Dj Ls Szwwr Ckur I Sgfu Pug Barcelona Spain
Uiqvqujezs Ok Acsiodf Edegem Belgium
Hnxgfisl Vgnz doxhajcf Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.06.2024
Bulgaria Bulgaria
Recruiting
01.06.2024
Czechia Czechia
Recruiting
01.06.2024
France France
Recruiting
01.06.2024
Germany Germany
Recruiting
01.06.2024
Hungary Hungary
Recruiting
01.06.2024
Italy Italy
Recruiting
01.06.2024
Poland Poland
Recruiting
01.06.2024
Romania Romania
Recruiting
01.06.2024
Slovakia Slovakia
Recruiting
01.06.2024
Spain Spain
Recruiting
01.06.2024

Trial locations

Lisaftoclax (APG-2575) is a medication being studied for its potential to help treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. It is being tested to see if it can improve the time patients live without their disease getting worse when used in combination with another medication.

Acalabrutinib is a medication that is already used to treat certain types of blood cancers, including chronic lymphocytic leukemia and small lymphocytic lymphoma. In this study, it is being used both alone and in combination with lisaftoclax to see if the combination can provide better outcomes for patients who have been previously treated with acalabrutinib.

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, the abnormal cells can crowd out healthy blood cells, leading to issues like anemia, infections, and bleeding problems. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression can vary greatly among individuals, with some experiencing rapid changes and others remaining stable for long periods.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. It involves the slow accumulation of small, mature lymphocytes in the lymph nodes, which can lead to swelling and discomfort. The disease progresses slowly, often without symptoms in the early stages. As it advances, it can cause symptoms such as fatigue, night sweats, and weight loss. The abnormal lymphocytes can also spread to other organs, including the liver and spleen. The progression rate can vary, with some individuals experiencing a stable condition for years.

Trial ID:
2023-508005-24-00
Protocol code:
APG2575CG301
NCT ID:
NCT06104566
Trial Phase:
Therapeutic confirmatory (Phase III)

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