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

An open label multi-center asciminib rollover 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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097880

Enrollment

357

Registered

2025-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive

Interventions

Intervention1: Asciminib: Asciminib 80 mg Tablet once daily orally for 242 weeks. Intervention2: Nilotinib: Nilotinib 300 mg Hard Gelatin Capsule twice daily orally for 242 weeks Intervention3: Imatin

Eligibility

Inclusion criteria

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) or study treatment received in the comparator arm while enrolled within a Novartis-sponsored study, who has fulfilled the requirements for the primary objective and has completed treatment phase and, in the opinion of the Investigator, would benefit from continued treatment.

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.Participantâ??s ongoing treatment is currently approved and reimbursed at country level. In exceptional cases where the treatment is reimbursed at country but not individual level, please contact the Novartis Study Team. 4.Pregnant or nursing (lactating) women. 5.Women of child-bearing potential unless they are using highly effective methods of contraception.

Design outcomes

Primary

Measure	Time frame
The frequency and severity of AEs/SAEsTimepoint: At every 12 weeks from baseline till end of treatment visit (Week 242) and Safety Follow-up visit (30 days after last dose)	—

Secondary

Measure	Time frame
Proportion of participants with clinical benefit as assessed by the investigator Timepoint: At every 12 weeks from baseline till Week 240.	—

Countries

Argentina, Austria, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Oman, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com02250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026