Study of venetoclax, obinutuzumab and zanubrutinib combination therapy in young patients with high-risk Chronic Lymphocytic Leukemia and residual disease

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What is this study about?

This study focuses on treating patients with Chronic Lymphocytic Leukemia who have not received previous treatment. The study examines a combination therapy using several medications: venetoclax, obinutuzumab, and zanubrutinib. Chronic Lymphocytic Leukemia is a type of blood cancer that affects white blood cells in bone marrow and blood.

The treatment begins with a combination of venetoclax and obinutuzumab for all participants. After this initial treatment, depending on how well patients respond, they will either continue receiving venetoclax alone or receive a combination of venetoclax with zanubrutinib. The purpose of this study is to evaluate how effective these drug combinations are at eliminating traces of cancer cells from the blood and bone marrow.

During treatment, patients may also receive supportive medications including chlorphenamine maleate, dexamethasone phosphate, paracetamol, allopurinol, lamivudine, and a combination of sulfamethoxazole and trimethoprim to manage potential side effects or prevent complications. The study will monitor patients’ response to treatment and track any side effects that may occur.

1 Initial treatment phase

Treatment begins with a combination of two medications: venetoclax (taken orally) and obinutuzumab (given by infusion)

This initial phase lasts for 9 months

Before starting treatment, you will receive medications to prevent possible complications: allopurinol, paracetamol, chlorphenamine maleate, and dexamethasone

2 Disease evaluation

After 9 months, your doctor will check the level of disease in your blood and bone marrow

Based on these results, you will be assigned to one of two treatment paths

3 Continuation phase

If minimal disease remains: you will continue taking only venetoclax (oral medication)

If higher levels of disease remain: you will receive a combination of venetoclax and zanubrutinib (both taken orally)

4 Follow-up evaluations

Regular disease level checks will occur at months 15, 21, 27, 33, and 36

These checks will involve blood tests and bone marrow examinations

The total duration of the study is 36 months (3 years)

Who Can Join the Study?

Age between 18 and 65 years
Female patients who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
Both male and female participants must agree to use effective birth control methods or abstain from sexual intercourse during treatment and:
- For 90 days after last dose of zanubrutinib
- For 30 days after last dose of venetoclax
- For 18 months after last dose of obinutuzumab
Must sign an informed consent document
Must be willing to follow study requirements
Must have confirmed CLL (Chronic Lymphocytic Leukemia) diagnosis according to current medical criteria
Must have good general health status with:
- Low illness burden score (CIRS less than 6)
- Adequate kidney function
- Good physical performance status
No previous treatment for CLL
Must have specific genetic markers in blood cells (unmutated IGHV, TP53 mutation, or deletion 17p)
Must have active disease requiring treatment
Must have adequate blood test results:
- Acceptable white blood cell counts
- Adequate platelet levels
- Sufficient hemoglobin levels
Must have normal liver function tests
Must have normal heart rhythm measurements (QT interval)

Who Cannot Join the Study?

Previous treatment for Chronic Lymphocytic Leukemia (a type of blood cancer)
Age over 65 years
Active or uncontrolled infections
Pregnant or breastfeeding women
Major surgery within 4 weeks before starting the study
Significant heart problems or uncontrolled heart disease
Severe liver disease
Severe kidney disease
Other active cancers requiring treatment
Known allergies to study medications
Mental conditions that could interfere with following study procedures
Participation in another clinical trial within 30 days
HIV, active hepatitis B, or hepatitis C infection
Uncontrolled autoimmune conditions (conditions where the immune system attacks healthy cells)
History of severe allergic reactions to biological treatments (medications made from living organisms)

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 Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno	Ascoli Piceno	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Ospedale S. Eugenio, ASL Roma 2	Rome	Italy
Aiiajep Orekssxvdcc Ucnpgcquluriq Pxasb	Parma	Italy
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Aqcfxzf Owxtuluumdl Odevpmrd Rfyvhdo Vqoep Slwqv Ccejegpw	Palermo	Italy
Ilqcdzoe Rleycpxei Pzg Lp Sjvorv Dep Tlirje Dodf Amobhnh Idjp Spbnqt	Meldola	Italy
Aqioxeb Oldxcvxawbw Urwpncvwsgcun Swypgz	Siena	Italy
Ainjqsa Oiamhsypexg Umiqkiyranvmm Cfzhxeugslpm Dedmy Stwxer E Dbrea Spffukg Dp Txiecz	Turin	Italy
Aiuaxbs Ooksihubopz Noavulwrt Sv Agdtnjw E Bvnydi E C Asvnpg Acilmunssky	Alexandria	Italy
Agaerwj Ukd Iuqqa Dp Rpodlp Ejikcq	Reggio Emilia	Italy
Udndsxulhc Dtpzl Snrkp Dp Rsjp Le Sxzdmvrw	Rome	Italy
Uthujhkweo Mocgt Gdokdak Ou Cmkxxodrn	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	21.07.2023

Trial locations

Investigated drugs:

Venetoclax
A medication used to treat chronic lymphocytic leukemia (CLL). It works by blocking a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax helps destroy cancer cells.

Obinutuzumab
A targeted therapy that attaches to a protein called CD20 found on certain blood cells. It helps your immune system identify and destroy cancer cells. This medication is given through an intravenous (IV) infusion.

Zanubrutinib
A medication that belongs to a class of drugs called BTK inhibitors. It works by blocking a protein that helps cancer cells grow and survive. This medication helps stop the growth and spread of cancer cells in patients with chronic lymphocytic leukemia.

Chronic Lymphocytic Leukemia – A slow-growing blood cancer that starts in white blood cells called lymphocytes in the bone marrow. These abnormal cells gradually increase and spread through the blood to lymph nodes and other organs. The disease develops when the bone marrow makes too many abnormal lymphocytes that don’t work properly. Over time, these cancerous cells can crowd out normal blood cells, leading to enlarged lymph nodes and a weakened immune system. The condition typically progresses slowly, and some people may not need immediate treatment after diagnosis.

Trial ID:

2023-510431-11-00

NCT ID:

NCT05478512

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of venetoclax, obinutuzumab and zanubrutinib combination therapy in young patients with high-risk Chronic Lymphocytic Leukemia and residual disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?