Last Update: Mar 22, 2024
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
ClinicalTrials.gov Identifier:
Novartis Reference Number:CABL001A2001B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is a long term safety study for patients who have completed a Novartis sponsored
asciminib study and are judged by the investigator to benefit from continued treatment This is an open-label, multi-center, global roll-over study designed to assess long term
safety and provide continued treatment to participants who have previously participated
in an asciminib Novartis sponsored study and who, in the opinion of the investigator,
would benefit from continued treatment as in the parent study, or from switching to
asciminib (if they were on bosutinib in the parent study), but are unable to access this
treatment outside of the clinical study.

Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Phase4
Recruiting
347
Aug 30, 2022
Aug 30, 2027
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Asciminib

Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state
Drug

Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state
Drug

Bosutinib

Taken orally, once daily, with food
Drug

Dasatinib

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Drug

Imatinib

Taken orally, once daily, in the morning with low-fat meal
Drug

Nilotinib

Taken orally, twice daily, on an empty stomach

Eligibility Criteria

Key Inclusion Criteria:

1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib
(single agent or in combination with imatinib, nilotinib or dasatinib), imatinib,
nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion
of the Investigator, would benefit from continued treatment.

2. Participant has demonstrated compliance on the parent study protocol and is willing
and able to comply with scheduled visits, treatment plans and any other study
procedures.

Key Exclusion Criteria:

1. Participant has been discontinued from parent study treatment.

2. Participant currently has unresolved toxicities reported as possibly related to
study treatment in the parent study.

3. Participant's ongoing treatment is currently approved and reimbursed at country
level.

4. Pregnant or nursing (lactating) women.

5. Women of child-bearing potential, unless they are using highly effective methods of
contraception and willing to continue while taking study treatment.

6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib
unwilling to follow the relevant contraception requirements in the local prescribing
information.

7. Applicable only for participants on bosutinib treatment that switch to asciminib
treatment at enrollment:

- Asymptomatic pancreatitis

- abnormal ECG

- any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days
before starting asciminib treatment

Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Location

Novartis Investigative Site

Recruiting

Caba,Buenos Aires,C1221adc,Argentina

Novartis Investigative Site

Recruiting

Wien,1140,Austria

Novartis Investigative Site

Recruiting

Sao Paulo,SP,05403 000,Brazil

Novartis Investigative Site

Recruiting

Sao Paulo,SP,08270-070,Brazil

Novartis Investigative Site

Recruiting

Rio de Janeiro,RJ,20211-030,Brazil

Novartis Investigative Site

Recruiting

Varna,9000,Bulgaria

Novartis Investigative Site

Recruiting

Montreal,Quebec,H1t 2m4,Canada

Novartis Investigative Site

Recruiting

Brno-Bohunice,639 00,Czechia

Novartis Investigative Site

Recruiting

Ostrava,Poruba,708 52,Czechia

Novartis Investigative Site

Recruiting

Copenhagen,Dk-2100,Denmark

Novartis Investigative Site

Recruiting

Vandoeuvre les Nancy,54511,France

Novartis Investigative Site

Recruiting

Marseille,13273,France

Novartis Investigative Site

Recruiting

Paris 10,75475,France

Novartis Investigative Site

Recruiting

Bordeaux,33076,France

Novartis Investigative Site

Recruiting

Frankfurt,60590,Germany

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Jena,07740,Germany

Novartis Investigative Site

Recruiting

Roma,RM,00161,Italy

Novartis Investigative Site

Recruiting

Napoli,80132,Italy

Novartis Investigative Site

Recruiting

Milano,MI,20162,Italy

Novartis Investigative Site

Recruiting

Monterrey,Nuevo Leon,64460,Mexico

Novartis Investigative Site

Recruiting

Warszawa,02 776,Poland

Novartis Investigative Site

Recruiting

Lisboa,1099 023,Portugal

Novartis Investigative Site

Recruiting

Porto,4200-072,Portugal

Novartis Investigative Site

Recruiting

Timisoara,300079,Romania

Novartis Investigative Site

Recruiting

St Petersburg,191024,Russian Federation

Novartis Investigative Site

Recruiting

Saint Petersburg,197341,Russian Federation

Novartis Investigative Site

Recruiting

Madrid,28006,Spain

Novartis Investigative Site

Recruiting

Valencia,46026,Spain

Novartis Investigative Site

Recruiting

Madrid,28034,Spain

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08036,Spain

Novartis Investigative Site

Recruiting

Hospitalet de LLobregat,Catalunya,08907,Spain

Novartis Investigative Site

Recruiting

Bilbao,Pais Vasco,48013,Spain

Novartis Investigative Site

Recruiting

Sevilla,Andalucia,41009,Spain

Novartis Investigative Site

Recruiting

Samsun,55139,Turkey

Novartis Investigative Site

Recruiting

Oxford,Ox3 7lj,United Kingdom

Uni of TX MD Anderson Cancer Cntr

Recruiting

Houston,Texas,77030,United States

Memorial Sloan Kettering

Recruiting

New York,New York,10017,United States

Michigan Med University of Michigan .

Recruiting

Ann Arbor,Michigan,48109 5271,United States

Worldwide Contacts

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Novartis Pharmaceuticals

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