Study for Adults with Chronic Myeloid Leukemia Using Asciminib Alone or with Nilotinib

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Chronic Myeloid Leukemia (CML), specifically a form that is positive for a genetic marker known as BCR-ABL1. The study is exploring the effectiveness of a medication called Asciminib, which can be used alone or in combination with another medication called Tasigna (nilotinib). Both medications are taken orally, with Asciminib available as film-coated tablets and Tasigna as hard capsules.

The purpose of the study is to evaluate how well these treatments work in achieving a deep molecular response, which means a significant reduction in cancer cells, in patients who are newly diagnosed with this type of leukemia. Participants will receive treatment over a period of time, and their response to the medication will be monitored regularly. The study aims to understand how quickly and effectively the treatments can reduce the presence of cancer cells in the blood.

Throughout the study, researchers will also observe the long-term outcomes for patients, including their overall survival and the possibility of maintaining remission without ongoing treatment. The study will help determine the best approach for using Asciminib and Tasigna in treating patients with Chronic Myeloid Leukemia who have the BCR-ABL1 marker. This research is important for improving treatment strategies and outcomes for individuals with this specific type of leukemia.

1 joining the study

Upon joining the study, you will be required to provide a signed written informed consent. This is a document that confirms your understanding of the study and your agreement to participate.

You will need to confirm your diagnosis of BCR-ABL1+ Chronic Myeloid Leukemia and meet specific health criteria, such as adequate organ function and a performance status that allows participation.

2 initial assessment

An initial assessment will be conducted to evaluate your health status and confirm eligibility. This may include blood tests and other diagnostic procedures to ensure you meet the study’s inclusion criteria.

3 treatment phase

You will begin treatment with either asciminib hydrochloride or a combination of asciminib hydrochloride and nilotinib. These medications are taken orally.

Scemblix is provided as 40 mg film-coated tablets, and Tasigna is provided as 150 mg hard capsules. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

4 ongoing monitoring

Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes blood tests to measure the levels of the BCR-ABL1 transcript, which helps determine the effectiveness of the treatment.

You may be required to visit the study site periodically for these assessments.

5 evaluation of response

The primary goal is to achieve a deep molecular response (MR4) within two years. This means a significant reduction in the BCR-ABL1 transcript levels.

If the molecular analysis is not evaluable, a repeat test may be conducted one month later.

6 long-term follow-up

The study will continue to monitor your health and response to treatment over several years. This includes evaluating sustained responses and overall survival rates.

You will be assessed for eligibility to discontinue treatment if certain response criteria are met.

Who Can Join the Study?

Confirmed diagnosis of Ph+ and BCR::ABL1+ CML. This means the patient has a specific type of chronic myeloid leukemia.
Must be 18 years or older.
In the early chronic phase of the disease, which means less than 3 months from diagnosis.
Evidence of specific BCR::ABL1 RNA transcripts (e13a2 or e14a2) at the time of study entry. These are specific genetic markers needed for reporting.
Previous treatment with any TKI (a type of cancer drug) for 30 days or less is allowed. Prior treatment with hydroxyurea or anagrelide is also allowed.
ECOG performance status of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities.
Adequate end organ function, which includes:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert’s syndrome who may have total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN.
- Aspartate transaminase (AST) ≤ 3.0 x ULN.
- Alanine transaminase (ALT) ≤ 3.0 x ULN.
- Serum amylase ≤ 1.5 x ULN.
- Serum lipase ≤ 1.5 x ULN.
- Alkaline phosphatase ≤ 2.5 x ULN, unless related to the tumor.
- Creatinine clearance > 50 ml/min using the Cockcroft-Gault formula. This measures kidney function.
Signed written informed consent according to international and local laws before any study procedure. This means the patient agrees to participate after understanding the study.
Use of an effective form of contraception with sexual partners from enrollment through 30 days after the end of treatment.

Who Cannot Join the Study?

Patients who do not have BCR-ABL1+ Chronic Myeloid Leukemia cannot participate. This is a specific type of blood cancer.
Patients who are not in the early phase of Chronic Myeloid Leukemia cannot participate. The early phase is the initial stage of the disease.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

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
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Ospedale dell’Angelo di Mestre	Mestre – Venezia	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliera di Padova	Padua	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
Hospital Universitario De Leon	Leon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Amtvycn Okjrkbfqyzl Ogvuthau Rsevyez Vxjaj Sdvma Cnylfygx	Palermo	Italy
Arrlnjg Oljnfponyji Ujgmogwaqyyzb Sybwvh	Siena	Italy
Asrivof Osaltxakpaa Ulyxwyugiufwi Cdmerjyditel Dvulb Suleon E Dzaja Skphgwa De Tikaud	Turin	Italy
Afebnnf Umt Ifokc Ds Rtwaez Eqrdbu	Reggio Emilia	Italy
Acneovo Ulqxl Swukayukj Ljahla Dv Bhiopam	Bologna	Italy
Uohqxltpcj Dhjef Sjspv Da Rcyo Lv Sbrvitqo	Rome	Italy
Imvtpklv Chswkm Dsmagkghbxzopvwub	L'hospitalet De Llobregat	Spain
Fzgoacsvw Pkhd Ly Iobodyaefqohk Bajkhmpqq Dds Hlvmogoz Uidmnznpjsdhp Lo Pqi	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	21.04.2025
Spain	Recruiting	21.04.2025

Trial locations

Investigated drugs:

Asciminib is a medication used in this clinical trial to treat a type of blood cancer called Chronic Myeloid Leukemia (CML). It works by specifically targeting and blocking a protein that helps cancer cells grow. By doing this, asciminib can help stop the cancer from progressing and may lead to a reduction in cancer cells in the body.

Nilotinib is another medication used in this trial, either alone or in combination with asciminib. It is also used to treat Chronic Myeloid Leukemia (CML). Nilotinib works by inhibiting the activity of a specific protein that is involved in the growth of cancer cells. This helps to slow down or stop the progression of the disease, potentially leading to a decrease in the number of cancer cells.

Investigated diseases:

Chronic myeloid leukaemia

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia (CML) is a type of cancer that starts in certain blood-forming cells of the bone marrow. It leads to the overproduction of abnormal white blood cells. The disease progresses slowly and can remain in a chronic phase for several years. Over time, CML can advance to an accelerated phase, where the disease becomes more aggressive. Eventually, it may progress to a blast crisis phase, resembling acute leukemia, with rapid growth of immature white blood cells. The progression of CML is driven by a genetic change known as the BCR-ABL1 fusion gene, which increases the activity of an enzyme called tyrosine kinase, leading to uncontrolled cell growth.

Trial ID:

2024-512696-12-00

Protocol code:

CML1624

NCT ID:

NCT06409936

Trial Phase:

Therapeutic exploratory (Phase II)

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Study for Adults with Chronic Myeloid Leukemia Using Asciminib Alone or with Nilotinib

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?