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Asciminib Roll-over Study
EU CTIS ID: 2023-507557-16-00
What this study is testing
The primary objective of this study is to assess long term safety data (i.e. Serious Adverse Events (SAEs) and Adverse Events (AEs)) of asciminib treatment in participants with Ph+CML-CP/-AP/-BP or Ph+ ALL that rollover from parent studies and provide continued access to study treatment received in the parent protocol.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Participant has been discontinued from parent study treatment due to any reason.
- 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.
- Participant’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.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using highly effective methods of contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
- United States
- Malaysia
- Singapore
- Russian Federation
- China
- Taiwan
- United Kingdom
- South Africa
- Lebanon
- Oman
- India
- Canada
- Korea, Republic of
- United Arab Emirates
- Turkey
- Brazil
- Japan
- Vietnam
- Argentina
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia; United States; Malaysia; Singapore; Russian Federation; China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.