Asciminib Roll-over Study

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: NCT04877522

Novartis Reference Number: CABL001A2001B

Last Update: Sep 28, 2022

See if you pre-qualify

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

Condition 
Chronic Myelogenous Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Aug 30, 2022
Completion date 
Aug 30, 2027
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Drug
Asciminib
Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state
Drug
Imatinib
Taken orally, once daily, in the morning with low-fat meal
Drug
Nilotinib
Taken orally, twice daily, on an empty stomach
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

Eligibility Criteria

Key Inclusion Criteria:

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.
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:

Participant has been discontinued from parent study treatment.
Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
Participant's ongoing treatment is currently approved and reimbursed at country level.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.

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 Locations

France
Novartis Investigative Site
Recruiting
Bordeaux, 33076
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Korea, Republic of
Novartis Investigative Site
Recruiting
Uijeongbu si, 11759
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Busan, 49201
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Jeollanam-do, 519763
-
Korea, Republic of
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Bilbao, 48013
Pais Vasco
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]