Study Comparing Asciminib with Other Drug Combinations for Adults with Newly Diagnosed Chronic Myeloid Leukemia

1 1 1 1

What is this study about?

This clinical trial is focused on studying a type of blood cancer called Chronic Myeloid Leukemia (CML), specifically in its early stage known as the chronic phase. The study is comparing the effectiveness of a new treatment called Asciminib Hydrochloride with other existing treatments chosen by doctors, which include Imatinib, Dasatinib, Nilotinib, and Bosutinib. These treatments are known as tyrosine kinase inhibitors (TKIs), which are medications that help block the growth of cancer cells.

The purpose of the study is to see how well Asciminib Hydrochloride works compared to the other TKIs in helping patients achieve a significant reduction in cancer cells, known as a Major Molecular Response, by the 48th week of treatment. Participants in the study will be randomly assigned to receive either Asciminib Hydrochloride or one of the other TKIs. The study will last for a period of up to 72 weeks, during which participants will take the medication orally, meaning by mouth, in the form of tablets or capsules.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to provide valuable information on the best treatment options for patients newly diagnosed with Chronic Myeloid Leukemia in the chronic phase. This research could help improve treatment strategies and outcomes for patients with this type of leukemia.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either asciminib or another medication chosen by the investigator. These medications are known as tyrosine kinase inhibitors (TKIs) and are used to treat chronic myeloid leukemia (CML).

2 medication administration

The participant will take the assigned medication orally. The specific dosage and frequency will be determined by the study protocol and the investigator’s decision. The medications involved in the study include imatinib, bosutinib, dasatinib, nilotinib, and asciminib hydrochloride.

3 monitoring and assessments

Throughout the study, the participant will undergo regular monitoring to assess the effectiveness of the treatment. This includes checking for a major molecular response (MMR) at specific intervals, such as Week 48 and Week 96. MMR is a measure of how well the leukemia is responding to treatment.

4 end of study

The study is expected to conclude by January 18, 2028. At the end of the study, the participant’s response to the treatment will be evaluated to determine the overall effectiveness of the medication.

Who Can Join the Study?

  • Participants must be male or female and at least 18 years old.
  • Participants should have been diagnosed with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) within the last 3 months.
  • The diagnosis of CML-CP must be confirmed by a test showing the presence of the Philadelphia chromosome, a specific genetic change.
  • Participants must have less than 15% blasts (immature blood cells) in their blood and bone marrow.
  • Participants must have less than 30% of blasts plus promyelocytes (a type of immature blood cell) in their blood and bone marrow.
  • Participants must have less than 20% basophils (a type of white blood cell) in their blood.
  • Participants must have a platelet count of at least 100,000 per cubic millimeter of blood.
  • There should be no evidence of leukemia outside the bone marrow, except for possible enlargement of the liver or spleen.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • Participants must have adequate function of their organs, including:
    • Total bilirubin (a substance made by the liver) less than 3 times the normal upper limit, unless they have a condition called Gilbert’s syndrome.
    • Creatinine clearance (a measure of kidney function) of at least 30 mL/min.
    • Serum lipase (an enzyme related to the pancreas) less than 1.5 times the normal upper limit.
  • Participants must have certain laboratory values within normal limits or corrected to normal with supplements, including:
    • Potassium, calcium, and magnesium levels.
  • Participants must sign an informed consent form before any study-related procedures are done.
  • Participants must have evidence of a specific genetic marker called BCR-ABL1 transcript that can be measured using a standardized test.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Chronic Myeloid Leukemia cannot participate. Chronic Myeloid Leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, but those who do not identify as either cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario De Navarra Pamplona Spain
University Hospital Jena KöR Jena Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
University Hospital St Marina Varna Varna Bulgaria
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Hospital Universitario Virgen De Las Nieves Granada Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Universitaetsklinikum Mannheim GmbH Mannheim Germany
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
University Hospital Ostrava Ostrava Czechia
Cjgjuz Lpdk Bdgfdw Lyon France
Ojaakrbhfhltvx Ljcp Gesl Linz Austria
Bwffynnhvoq Vwmrmcqcn Onmptmohpmpg Kecskemet Hungary
Ijvrwxuu Bvglgtwr Bordeaux France
Agnuoxddlr Pjyfzgje Hxzouqfx Dp Plixj Paris France
Hyglu Bureab Hk Bergen Norway
Hasxwiba Ubczrbbnpr Cbdmpbv Hrttmrbz Helsinki Finland
Apdlcl Uocuzuewye Heejlzde Aarhus Denmark
Gkswwf Utdpqocugl Fcxszvblg Frankfurt Germany
Abvytru Uzu Iqfkm Dg Rxmaiw Eaimsw Reggio Emilia Italy
Atdkdmt Urpcu Svrvqpebj Lpeqeb De Bdkatjq Bologna Italy
Uudqiepqyr Dmkvf Sslgw Dy Rypq Lw Suigcqdk Rome Italy
Fhutzscgn Pnvt Lw Ibrdglccindhv Bennvrvgi Did Hkijeyit Ubqaunbmqstmd Li Psb Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
06.10.2021
Belgium Belgium
Not recruiting
06.10.2021
Bulgaria Bulgaria
Not recruiting
06.10.2021
Czechia Czechia
Not recruiting
06.10.2021
Denmark Denmark
Not recruiting
06.10.2021
Finland Finland
Not recruiting
06.10.2021
France France
Not recruiting
06.10.2021
Germany Germany
Not recruiting
06.10.2021
Hungary Hungary
Not recruiting
06.10.2021
Italy Italy
Not recruiting
06.10.2021
Norway Norway
Not recruiting
06.10.2021
Portugal Portugal
Not recruiting
06.10.2021
Slovakia Slovakia
Not recruiting
06.10.2021
Spain Spain
Not recruiting
06.10.2021
Sweden Sweden
Not recruiting
06.10.2021

Trial locations

Asciminib is a medication being studied for its effectiveness in treating patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in the chronic phase. It is taken orally and works by specifically targeting and inhibiting a protein that is involved in the growth of cancer cells. The goal is to see if asciminib can help more patients achieve a significant reduction in cancer cell levels by Week 48 of treatment.

Investigator Selected TKI refers to a group of medications known as tyrosine kinase inhibitors (TKIs) that are chosen by the study investigators for comparison against asciminib. These medications are commonly used to treat chronic myelogenous leukemia by blocking the action of proteins that promote the growth of cancer cells. The study aims to compare the effectiveness of asciminib with these TKIs in achieving a major molecular response in patients.

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia (CML) is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as myeloid cells. These cells gradually accumulate in the blood and bone marrow, interfering with the production of normal blood cells. CML typically progresses through three phases: chronic, accelerated, and blast crisis, with each phase showing an increase in the number of abnormal cells. In the chronic phase, symptoms may be mild or absent, but as the disease progresses, symptoms such as fatigue, weight loss, and an enlarged spleen may occur. The disease is often associated with a specific genetic abnormality known as the Philadelphia chromosome.

Trial ID:
2023-508838-33-00
Protocol code:
CABL001J12301
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Long-Term Safety Study of Asciminib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1 1
    Investigated diseases:
    Austria Bulgaria Czechia Denmark France Germany +8
  • Study for Adults with Chronic Myeloid Leukemia Using Asciminib Alone or with Nilotinib

    Recruiting

    1 1 1
    Investigated diseases:
    Italy Spain