Asciminib Roll-over Study

Chronic Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877522
• Other study ID #: CABL001A2001B
• Secondary ID: 2021-000602-17
• Status: Recruiting
• Phase: Phase 4
• Start date: August 30, 2022
• Est. completion date: August 30, 2030

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 347
• Est. completion date: August 30, 2030
• Est. primary completion date: August 29, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
• Asciminib
Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state
• Imatinib
Taken orally, once daily, in the morning with low-fat meal
• Nilotinib
Taken orally, twice daily, on an empty stomach
• Bosutinib
Taken orally, once daily, with food
• Dasatinib
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Austria	Novartis Investigative Site	Wien
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Bulgaria	Novartis Investigative Site	Varna
Canada	Novartis Investigative Site	Montreal	Quebec
Czechia	Novartis Investigative Site	Brno-Bohunice
Czechia	Novartis Investigative Site	Ostrava	Poruba
Denmark	Novartis Investigative Site	Copenhagen
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Paris 10
France	Novartis Investigative Site	Vandoeuvre les Nancy
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Jena
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma	RM
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Jeollanam
Korea, Republic of	Novartis Investigative Site	Uijeongbu si	Gyeonggi Do
Lebanon	Novartis Investigative Site	Beirut
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Saudi Arabia	Novartis Investigative Site	Riyadh
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Hospitalet de LLobregat	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia
Taiwan	Novartis Investigative Site	Taoyuan
Turkey	Novartis Investigative Site	Samsun
United Kingdom	Novartis Investigative Site	Oxford
United States	Michigan Med University of Michigan .	Ann Arbor	Michigan
United States	Uni of TX MD Anderson Cancer Cntr	Houston	Texas
United States	Memorial Sloan Kettering	New York	New York
United States	Oregon Health Sciences University .	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Mexico,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Singapore,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participabts with adverse events (AEs) and serious adverse events (SAEs)	All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.	5 years
Secondary	Percentage of participants with clinical benefit as assessed by Investigator	Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.	5 years