Male and female adult participants (= 18 years) with Ph+ CML or Ph+ ALL at the end of parent study, who are currently participating in an asciminib Novartis sponsored parent study MedDRA version: 21.0 Level: LLT Classification code 10009012 Term: Chronic myelogenous leukemia System Organ Class: 100000004864 MedDRA version: 21.0 Level: PT Classification code 10034877 Term: Philadelphia chromosome positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Asciminib
Product Code: ABL001
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ASCIMINIB
Current Sponsor code: ABL001
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Participant with Ph+ CML or Ph+ ALL, currently enrolled in a Novartis-sponsored study, that has completed treatment phase and has fulfilled the requirements for the primary objective, receiving: -asciminib -asciminib in combination with imatinib or nilotinib or dasatinib -imatinib -nilotinib -bosutinib and, in the opinion of the Investigator, would benefit from continued treatment. 3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements and is willing and able to comply with scheduled visits, treatment plans and any other study procedures. 4. Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260
Exclusion criteria
Exclusion criteria: 1. Participant has been discontinued from parent study treatment due to any reason. 2. Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have: - not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities, - not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities. 3. Participant’s ongoing treatment is currently approved and reimbursed at country level. 4. Pregnant or nursing (lactating) women. 5b. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 days after stopping asciminib. If local regulations or locally approved prescribing information are more stringent than the protocol required duration of contraception (Section 8.4.3), local regulations or locally approved prescribing information apply and will be described in the ICF. Participants receiving imatinib, nilotinib bosutinib or dasatinib should be willing to follow the respective contraception requirements as in the local prescribing information. 6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib should be willing to follow the relevant contraception requirements as in the local prescribing information. 7a. Applicable only for participants on bosutinib treatment at the end of the CABL001A2301 study that switch to asciminib treatment at enrollment: -Any Grade 3 or 4 toxicity which has not resolved to Grade 2 or lower within 28 days before starting asciminib treatment. -Asymptomatic (grade 2) pancreatitis if not resolved within 28 days. -QTcF > 480 msec or inability to determine QTc interval 8. Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess long term safety data and provide continued access to study treatment received in the parent protocol.;Secondary Objective: The secondary objective of this study is to evaluate clinical benefit as assessed by the Investigator.;Primary end point(s): The frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: End of Study of 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits;Timepoint(s) of evaluation of this end point: End of Study of 5 years | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Canada, China, Czechia, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactInformacní služba – klin. hodnocení
Novartis s.r.o
Outcome results
None listed