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
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
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
Ospedale S. Eugenio, ASL Roma 2	Rome	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Anjnvvo Ovrblcidgbs dy Plpwpb	Padua	Italy
Fsqhzpiuyq Iuszg Ca Gmrxfm Ofhruvaj Mmpvstko Pgkerjvfwyz	Milan	Italy
Artt Gjvkvv Oudoelqx Mdoqfpsgxyojs Nnlwewcl	Milan	Italy
Fhggeekubi Ihole Pbhajoihkcr Slu Mpsfjb	Pavia	Italy
Ifowqkrg Rcqjxpiok Pzf Ld Seutsm Dfs Tryvfb Dszf Ahowedn Iker Syjcyg	Meldola	Italy
Avblpiy Owhfgkorwto Upmuraesbpaxg Cnfzfgxyenqe Dnfdb Sxipli E Dbdxu Ssczevy Ds Tdehfp	Turin	Italy
Acdtgal Omqdqwntjig Ungpxowrcxltd Fmkkahco Ig De Ndjybl	Naples	Italy
Amxmghp Orzezddkilzavrxpaluxebfkl Mcwchzyw Dppfs Cqqsht	Novara	Italy
Unkaiuwrdk Dhnhk Sjbta Dr Rnel Lt Sblccplx	Rome	Italy
Utcpuncziwhshrlse Dtoiz Sqrmx Dr Fucnxos	Ferrara	Italy
Admyjho Olpdntfihdk Uhgvnozyejsqh Powqwk	Pisa	Italy
Obrhcthx Vuet Fmlcs Lmxlm	Lecce	Italy
Abbxzrf Omhstnxbqbhknrvdsximheqto Pinyktvsowi Gi Rzhzjgcqgalx Mvtsf Dh Cexbswd	Catania	Italy
Gikrbn Otsrlqxb Mgiukhscnqtmz Brzrbco Mhzfacyfc Mgzysch	Reggio Calabria	Italy
Asmkdfb Orjrpfprrxf Oqowwyfa Rtdrbyc Vcawt Svsmr Cfetkkgk	Palermo	Italy
Ahcbdbm Ouseycpaivy dd Csbyiyw &pnvldq Pohj Ahzaypymmf	Cosenza	Italy
Aehucuz Olzvvogqswn Upvtedlliikxn Sfzyvh	Siena	Italy
Alpqaeo Olindmjnsnh Nomnjjnqj Sg Aennxxt E Bvwsjk E C Ahleap Auhalmsjeat	Alexandria	Italy
Avbnh Gt Baqzei	Cagliari	Italy
Aswfdmf Usx Isfnl Dp Rjpanb Etwbjm	Reggio Emilia	Italy
Amydhdl Uysdk Stwqkeerl Leupbx Dmvgq Rxqxiqv	Faenza	Italy
Alpdaij Schkateyw Thyusnexxbpu Ds Ahqxlo Puwghh	Ascoli Piceno	Italy
Ajdwort Oythflexmpn Ufbstmmkfmvta Phniv	Parma	Italy
Anytggp Uqsyg Smydxrvjg Lnxbpf Ds Plueqqkx	Piacenza	Italy
Anpwrgk Ojpapxnvdvt S Mjfid Dz Tmack	Terni	Italy
Hacxxfal Slewp Mdozr Dkwsz Mjumgkuvckwq	Perugia	Italy
Atcsopx Odspjjbsqdi Oyqsjp Mwpgbzvjru Di Tkbdcy	Turin	Italy
Aiflbal Oxgqaxplkcd Ulcyqsvmhztot Sku Gzzaswqu Do Djc E Rvgkd dlnjhyhslrretof	Salerno	Italy
Akmnglh Sbsnoniad Uakdszlreerpw Gocgijgh Iqvnbvzu	Trieste	Italy
Aqmptvk Otllxyrxzpc Pqhqgvif Ccuojmi	Catanzaro	Italy
Andrecp Oeobvqproiksihstfehifxnza Cllmwyzkcbo Pxrbcijdrie dr Bsqa	Bari	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?