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

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What is this study about?

This study is for people with chronic myelogenous leukemia (also called CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It is an open-label study, which means the treatment is known to the study team and the participants. The treatment used in the study is asciminib hydrochloride, taken by mouth. The purpose of the study is to check the long-term safety of continuing asciminib after a previous study.

The study follows people who have already completed an earlier asciminib study and are considered by the doctor to still benefit from treatment. Treatment is continued over time, and regular study visits are planned so that health and any side effects can be watched. The study looks at possible adverse events, which are unwanted health problems that happen during treatment, and serious adverse events, which are more severe health problems. In some parts of the study, other tyrosine kinase inhibitors that may have been used in earlier studies include nilotinib, dasatinib, imatinib, and bosutinib.

The study is designed to provide continued access to the same study treatment received before while long-term safety is followed over time.

Who Can Join the Study?

  • You must have Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The Philadelphia chromosome is a change in the leukemia cells’ chromosomes, which are the structures that carry genes.
  • You must be currently receiving asciminib, either by itself or together with imatinib, nilotinib, or dasatinib. These are medicines used to treat leukemia.
  • Or, if you were in the comparator arm of a Novartis-sponsored study, you must be receiving the study treatment that was assigned in that group. A comparator arm is the group used for comparison in a clinical trial.
  • You must have already met the requirements for the main part of the study and have finished the treatment phase.
  • The study doctor must think that you would benefit from continuing treatment.

Who Cannot Join the Study?

  • The person was stopped from treatment in the parent study for any reason.
  • The person still has severe side effects from the parent study that are thought to be possibly related to the study treatment. Grade 3 or 4 means a serious or very serious side effect. These side effects must not have improved to Grade 2 or lower within the allowed time: 42 days for blood-related side effects, or 28 days for side effects not related to blood.
  • The person needs to stop study treatment for longer than the allowed time because of ongoing side effects: more than 42 days for hematological toxicities (blood-related side effects) or more than 28 days for non-hematological toxicities (side effects not related to blood).
  • The person’s current treatment is already approved and paid for at the country level. This means the treatment is already available through normal care in that country.
  • The person is pregnant.
  • The person is breastfeeding or nursing.
  • The person is a woman who can become pregnant and is not using a highly effective method of birth control.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Laiko General Hospital Of Athens Athens Greece
Institut Paoli-Calmettes Cancer Centre Marseille France
EVAGGELISMOS”General Hospital of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
Centre Hospitalier Universitaire De Caen Normandie Caen France
Universitaetsklinikum Erlangen AöR Erlangen Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Philipps-Universitaet Marburg Marburg Germany
University Hospital Jena KöR Jena Germany
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Universidade De Santiago De Compostela Santiago De Compostela Spain
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
CHRU De Nancy Vandoeuvre Les Nancy France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Rigshospitalet Copenhagen Denmark
Centre Leon Berard Lyon France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
University Medical Center Hamburg-Eppendorf Hamburg Germany
Oncopole Claudius Regaud Toulouse France
Universita Degli Studi Di Roma La Sapienza Rome Italy
Ordensklinikum Linz GmbH Linz Austria
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario De La Princesa Madrid Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Fakultni Nemocnice Plzen Plzen Czechia
Spitalul Clinic Coltea Bucharest Romania
Assistance Publique Hopitaux De Paris Paris France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Goethe University Frankfurt Frankfurt Germany
Centre Hospitalier Universitaire De Poitiers Poitiers France
Martin-Luther-Universitaet Halle-Wittenberg Halle (Saale) Germany
Universitaetsklinikum Augsburg Augsburg Germany
University Hospital Bratislava Bratislava Slovakia
Instytut Hematologii I Transfuzjologii Warsaw Poland
Hospital Universitario Basurto Bilbao Spain
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
University Hospital Ostrava Ostrava Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
IRCCS Istituto Giannina Gaslini Genoa Italy
Semmelweis University Budapest Hungary
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Nice Nice France
Medical University Of Graz Graz Austria
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany

Other Sites

Site Name City Country Status
Fundeni Clinical Institute Bucharest Romania
Spitalul Clinic Municipal De Urgenta Timisoara Timisoara Romania
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medicinski Centar Hipokrat-N EOOD Plovdiv Bulgaria
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
University Hospital St Marina Varna Varna Bulgaria
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
Klckcuxf Cjcysgst giche Chemnitz Germany
Aytzbsg Syxfjmpbg Lakloa Rnoa 2 Rome Italy
Htrnil Kvfocirp Bke Snxjdh Gbma Bad Saarow Germany
Ibvrtlwae On Hohbxjtdjw Abx Byxnm Tflagqlllgt Prague Czechia
Mlyonjsytkwgb Hmwnvlls fni Aeppuw Tfexeepzy Hctpr aqd Bjsng Eox Pleven Bulgaria
Hfwdziaulmqukybiczhzc Gcnbpwgtcogtuihmmtl Pzahho umu Fiirgccvyjjxrxkiu Gts Munich Germany
Pwdmpf Onkujjzpi Kysapyty Katowice Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.08.2022
Bulgaria Bulgaria
Recruiting
30.08.2022
Czechia Czechia
Recruiting
30.08.2022
Denmark Denmark
Not recruiting
30.08.2022
France France
Recruiting
30.08.2022
Germany Germany
Recruiting
30.08.2022
Greece Greece
Not yet recruiting
30.08.2022
Hungary Hungary
Not yet recruiting
30.08.2022
Italy Italy
Recruiting
30.08.2022
Poland Poland
Recruiting
30.08.2022
Portugal Portugal
Recruiting
30.08.2022
Romania Romania
Recruiting
30.08.2022
Slovakia Slovakia
Not yet recruiting
30.08.2022
Spain Spain
Recruiting
30.08.2022

Trial locations

Asciminib is the main study medicine in this trial. It is taken by mouth and is being continued in people who already used it in a previous study and were thought to still benefit from it. The trial is mainly looking at how safe long-term use of this medicine is, including any serious side effects or other unwanted effects over time.

Nilotinib is another oral cancer medicine included in the study group. It is used as an active treatment option for people with certain blood cancers, and the trial includes participants who may have received this medicine before or who are being followed while on it. The study helps monitor how safe it is when used over a longer period.

Dasatinib is an oral treatment used for some types of leukemia. In this trial, it is one of the active medicines that participants may have been receiving in parent studies before rolling over into this long-term safety study. Its role here is to continue treatment and watch for side effects during ongoing use.

Imatinib is an oral medicine used to treat certain blood cancers. It is included as an active treatment option in the study for participants who were already taking it in earlier studies. The trial follows patients who stay on this medicine to better understand its long-term safety and tolerability.

Bosutinib is an oral cancer medicine that may be used in people with certain leukemia types. It appears in the study as another active treatment that participants may continue from a previous trial. The study is not testing whether it works better, but rather tracking safety while treatment continues over time.

Chronic myelogenous leukemia – A cancer of the blood and bone marrow that begins with too many immature white blood cells. It usually develops slowly at first, then can progress through a more active phase and, in some cases, to a more advanced phase with faster growth of abnormal cells. The disease may cause the bone marrow to make fewer normal blood cells over time. Philadelphia chromosome-positive acute lymphoblastic leukemia – A fast-growing cancer of the blood and bone marrow that starts from very early lymphoid cells. It develops quickly as abnormal cells build up and crowd out normal blood cells. The disease can worsen as these immature cells continue to multiply and spread within the marrow and blood.

Trial ID:
2023-507557-16-00
Protocol code:
CABL001A2001B
Trial Phase:
Therapeutic confirmatory (Phase III)

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