Study of Ibrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia or Similar Conditions

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What is this study about?

This clinical trial is focused on studying the treatment of a condition called Autoimmune Hemolytic Anemia (AIHA) in patients who have Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), as well as those with a condition similar to CLL known as CLL-like monoclonal B-cell lymphocytosis. The treatment being tested in this study is a medication called Ibrutinib, which is taken in the form of a hard capsule. Ibrutinib is a chemical substance that is designed to help manage these conditions.

The purpose of this study is to evaluate how effective Ibrutinib is in treating AIHA in patients with CLL, SLL, or CLL-like conditions. Participants in the study will take Ibrutinib orally, and the study will be conducted over a period of time with several cycles of treatment. Each cycle lasts 28 days, and the study will assess the response of AIHA after 6 cycles. Additionally, the study will look at the response after 3 and 12 cycles, as well as other factors like the duration of the response, the need for blood transfusions, and any side effects related to the treatment.

Throughout the study, researchers will also monitor the overall health and quality of life of the participants, as well as specific responses related to CLL. The study aims to provide valuable information on the effectiveness and safety of Ibrutinib for patients with these conditions, helping to improve treatment options in the future.

1 joining the study

Upon joining the study, the patient will be required to provide written informed consent. This ensures understanding and agreement to participate in the trial.

Eligibility will be confirmed based on specific criteria, including a diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis (MBL).

2 treatment initiation

The patient will begin treatment with ibrutinib, an oral medication. The dosage and frequency will be determined by the study protocol.

The treatment is designed to assess the effectiveness of ibrutinib in treating autoimmune hemolytic anemia (AIHA) in patients with CLL/SLL or CLL-like MBL.

3 treatment cycles

The treatment will be administered in cycles, each lasting 28 days. The primary endpoint is to assess AIHA overall response rate (ORR) after 6 cycles.

Secondary assessments will occur after 3 and 12 cycles, evaluating various response rates and survival metrics.

4 monitoring and assessments

Throughout the trial, the patient will undergo regular monitoring to assess the response to treatment and any potential side effects.

Quality of life and other health parameters will be evaluated at baseline and after 3, 6, and 12 cycles.

5 completion of treatment

Upon completion of the treatment cycles, the patient’s response to ibrutinib will be thoroughly evaluated.

The study aims to conclude by November 2026, with ongoing assessments to ensure patient safety and treatment efficacy.

Who Can Join the Study?

Must have a diagnosis of Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis (MBL) according to specific guidelines.
Men and women of childbearing potential, and their partners, must agree to use birth control methods until the end of the treatment.
Men must agree not to father a child or donate sperm while taking the study medication and for 3 months after finishing treatment.
Must be over 18 years old.
Must have active Autoimmune Hemolytic Anemia (AIHA), which is a condition where the immune system destroys red blood cells. This includes:
- AIHA that has returned after previous treatment with steroids, with or without another medication called rituximab.
- AIHA that does not respond to steroids within 3 weeks.
- AIHA that requires ongoing steroid treatment to maintain a response.
For patients with a specific type of AIHA that does not show certain test results, eligibility must be confirmed by the trial’s main doctors.
Must sign a written consent form agreeing to participate, following international and local laws.
Must have a performance status of 2 or less on a scale used to assess how the disease affects daily living abilities.
Must have adequate kidney and liver function based on specific laboratory tests.
Must be able to swallow the study medication in pill form.
Women who can become pregnant must have a negative pregnancy test before starting the study medication and take monthly tests until the end of treatment.

Who Cannot Join the Study?

Patients who do not have Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) cannot participate. These are types of blood cancers.
Patients who do not have CLL-like monoclonal B-cell lymphocytosis cannot participate. This is a condition where there are too many of a certain type of white blood cell in the blood.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Aetkmpd Okklxrzazrq do Crjrbrv &sdmaxr Pila Anykczzlgw	Cosenza	Italy
Aifusd Abesaxr Bhlqvx e Cqkxdm Auvdtf Aodxrpapszj	Alexandria	Italy
Heafvaqku Chsrvom	Catania	Italy
Acfrznx Ofzvbetkchd Ubuiobfisfcwx Czdnudebidvn Dysso Slbwrv E Dmrad Senpqpw Dj Tckivd	Turin	Italy
Ufxkjijxjd Dprvr Satwc Ds Rmnx Lf Sunagswh	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	24.11.2023

Trial locations

Investigated drugs:

Ibrutinib

Ibrutinib is a medication used in this clinical trial to treat autoimmune hemolytic anemia in patients who have chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis. It works by blocking a specific protein that helps cancer cells grow and survive, which may help to improve the condition of patients with these types of blood disorders.

Investigated diseases:

Chronic lymphocytic leukaemia

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 fatigue, infections, and swollen lymph nodes. As the disease advances, it can affect the body’s ability to fight infections and may cause anemia or bleeding problems. The progression can vary greatly among individuals, with some experiencing rapid changes while others remain stable for long periods.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that is closely related to chronic lymphocytic leukemia, involving the same type of cancerous lymphocytes. It primarily affects the lymph nodes rather than the blood and bone marrow. The disease progresses slowly, often without symptoms initially, but can lead to swollen lymph nodes, fatigue, and weight loss over time. As it advances, it may spread to other parts of the body, including the liver and spleen. The progression rate can vary, with some individuals experiencing a stable condition for years.

CLL-like Monoclonal B-cell Lymphocytosis – This condition involves the presence of abnormal B-cells in the blood, similar to those seen in chronic lymphocytic leukemia, but in smaller numbers. It is often considered a precursor to CLL, though not all cases progress to leukemia. The condition typically does not cause symptoms and is often found incidentally during blood tests. Over time, it may remain stable or progress to CLL, but the progression is generally slow. Monitoring is usually required to track any changes in the condition.

Trial ID:

2023-509793-38-00

Protocol code:

CLL2323

NCT ID:

NCT05694312

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ibrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia or Similar Conditions

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