Comparison of Nilotinib versus Imatinib treatment in newly diagnosed chronic myeloid leukemia patients to achieve treatment-free remission

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What is this study about?

This study focuses on patients with Chronic Myeloid Leukemia (CML) in its chronic phase, which is a type of blood cancer affecting white blood cells. The study compares two medications: Nilotinib (Tasigna) and Imatinib (Glivec), which are both taken as hard capsules by mouth. These medications work by targeting specific proteins that cause the abnormal growth of cancer cells.

The purpose of this research is to determine if starting treatment with Nilotinib is more effective than starting with Imatinib and then switching to Nilotinib if the initial response is not optimal. The study will examine how well these treatments work in helping patients achieve and maintain a treatment-free period where their disease remains under control without ongoing medication.

During the study, which lasts up to 48 months, patients will receive either Nilotinib (up to 600 mg daily) or Imatinib (up to 400 mg daily). Doctors will monitor the amount of cancer cells in the blood throughout the treatment period to determine how well the medications are working. The study will track how many patients can successfully stop treatment while maintaining control of their disease.

1 Initial treatment phase

You will be assigned to receive either Nilotinib (Tasigna 150 mg capsules) or Imatinib (Glivec 100 mg capsules)

Both medications are taken by mouth as hard capsules

Your treatment will be monitored regularly to check how well it works

2 Treatment adjustment

If you started with Imatinib and your response is not optimal, your treatment will be changed to Nilotinib

Regular blood tests will measure the levels of specific markers in your blood to determine how well the treatment is working

3 24-month evaluation

At 24 months, your doctor will check for a deep molecular response (a measure of how well the treatment is controlling the disease)

This evaluation helps determine the next steps in your treatment

4 Treatment-free period

If your disease responds well to treatment, you may enter a period without medication

During this time, regular monitoring will continue to ensure the disease remains under control

This phase will be monitored for at least 12 months to check if the disease remains stable without treatment

5 Long-term follow-up

Your health will be monitored for up to 60 months (5 years)

Regular check-ups will assess your overall health and how well the disease is controlled

Quality of life assessments will be conducted throughout the study period

Who Can Join the Study?

Must be at least 18 years old
Must have confirmed diagnosis of BCR/ABL+ Chronic Myeloid Leukemia in chronic phase with:
- Less than 15% blasts in blood
- Less than 30% blasts plus promyelocytes in blood
- Less than 20% basophils in blood
- Platelet count equal or greater than 100,000 per mm3
Must have ECOG performance status of 0-2 (ability to perform daily activities from fully active to being up more than 50% of waking hours)
Must have evidence of typical BCR-ABL transcripts that can be measured by standardized testing
Must have adequate organ function shown by:
- Normal or slightly elevated bilirubin levels (liver function)
- Liver enzymes (AST and ALT) no more than 3 times above normal
- Pancreatic enzymes (amylase and lipase) no more than 2 times above normal
- Alkaline phosphatase no more than 2.5 times above normal
- Kidney function (creatinine) no more than 1.5 times above normal
Must provide written informed consent before any study procedures

Who Cannot Join the Study?

Age below 18 years or above 65 years
Previous treatment with any medication for Chronic Myeloid Leukemia (CML)
Pregnant or breastfeeding women
Active or uncontrolled infections
Significant heart problems, including:
- Uncontrolled high blood pressure
- Recent heart attack (within past 6 months)
- Unstable heart rhythm disorders
Severe liver problems or abnormal liver function tests
Severe kidney problems or abnormal kidney function tests
Other types of cancer in the past 5 years
Mental conditions that could affect ability to follow study requirements
Participation in other clinical trials within past 30 days
Known allergies to study medications
Conditions that could interfere with oral medication absorption
Use of medications that could interact with study drugs

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
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Ospedale dell’Angelo di Mestre	Mestre – Venezia	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliera Papardo	Messina	Italy
Ospedale Santa Maria Goretti Latina	Latina	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Ospedale Di Sassuolo S.p.A.	Sassuolo	Italy
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Meander Medical Center	Amersfoort	The Netherlands
Reinier de Graaf Groep	Delft	The Netherlands
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Spaarne Gasthuis	Hoofddorp	The Netherlands
Ospedale S. Eugenio, ASL Roma 2	Rome	Italy
Alwdefd Oqiaunljjid Ugkpgojqmxprr Ppkyc	Parma	Italy
Urab 6 Exljbqaj Ogunwelw Czffgczdwhpey &gollff Cydgtifxin	Camposampiero	Italy
Aixuz 5 Pxnocaxhp Pmeodsln Oprilrrdtlh Dp Runeho	Rovigo	Italy
Avd Dhmpb Pwyhynnwp Du Bkvdeduqv Atlitkv Tpfwbl Ohywnhyh &mrlfwhwmlbh Dyqwmdmutoqovbmw &oknvlr Bvmpelnr	Barletta	Italy
Plee Sjyid Myawt Lkbmug Nzjsrf Abh Nlejwv 1 Cezrwnnv	Naples	Italy
Aqkguka Orrtezdjaxj dn Cpiaogf &rjqkgm Pnsc Aarcwwpxea	Cosenza	Italy
Iloasuow Rkwafhxwt Pvj Lq Sdqpzx Dgp Tdjgsj Djvi Ahujadf Inax Sljvcr	Meldola	Italy
Aqiujkjeb Uuh	Amsterdam	The Netherlands
Afhxfod Odrmjiwgprr Ulltcutixvxgy Sbmcou	Siena	Italy
Aqsrwjt Orazhfvzrwu Uunbgbgzmskvk Ccnmvltwaciv Duqhm Sbyaxt E Dbeei Skgkdod Dk Tigoeg	Turin	Italy
Ayxdpav Okbdskghnxr Nfekslcfn Sw Ahirrlv E Btjbiv E C Admmvz Alufzikqgxw	Alexandria	Italy
Aldsseu Uxq Iqxna Da Rrmoyg Eyfvef	Reggio Emilia	Italy
Akvjrwo Udutx Spqksgltq Lgrrre Df Bmmtajh	Bologna	Italy
Arapqpv Onbuvhwasut Pzzd Ggkpcurv Xtqdv	Bergamo	Italy
Uurjpzjwar Djhkv Slyqh Dw Rffj Lm Siaogzae	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	11.11.2016
The Netherlands	Not recruiting	11.11.2016

Trial locations

Investigated drugs:

Nilotinib is a medication used to treat chronic myeloid leukemia (CML). It works by blocking certain proteins that cause cancer cells to grow and multiply. This medication helps control the disease and may lead to long-term remission in patients with CML.

Imatinib is also a medication used to treat chronic myeloid leukemia. It works by targeting specific proteins that are responsible for cancer cell growth. This was one of the first targeted therapies developed for CML and has been used successfully for many years to help patients manage their condition.

Both medications belong to a class of drugs called tyrosine kinase inhibitors, which work by blocking signals that cancer cells need to grow. The trial compares these treatments to find the most effective approach for achieving treatment-free remission in patients with chronic myeloid leukemia.

Investigated diseases:

Chronic myeloid leukaemia

Chronic Myeloid Leukemia (CML) – A type of blood cancer that begins in the bone marrow, causing the body to produce too many white blood cells. The disease typically develops slowly during its chronic phase, which is characterized by an excessive production of mature and maturing granulocytes (a type of white blood cell). During the chronic phase, patients may experience mild symptoms such as fatigue, weight loss, night sweats, or an enlarged spleen. The condition is marked by the presence of a specific genetic change called the Philadelphia chromosome in the blood cells. CML in chronic phase is generally stable and develops more gradually compared to other forms of leukemia.

Trial ID:

2023-510434-83-00

Protocol code:

CML1415 – Sustrenim

NCT ID:

NCT02602314

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of Nilotinib versus Imatinib treatment in newly diagnosed chronic myeloid leukemia patients to achieve treatment-free remission

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?