RightFit
RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
7 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks the long-term safety of continued treatment after a Novartis-sponsored asciminib study. It is for people with certain types of leukemia whose study doctor thinks continued treatment would help them.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have PH+ CML or PH+ ALL, types of blood cancer with a gene change called the Philadelphia chromosome.
  • Be receiving treatment in a Novartis-sponsored study: asciminib alone or with imatinib, nilotinib, or dasatinib; or imatinib, nilotinib, or bosutinib alone.
  • Your study doctor thinks you would benefit from continued treatment.
  • Have followed the earlier study's rules and be willing and able to follow this study's visit schedule, treatment plan, and other steps.

Who can't join

  • Your treatment in the earlier study was stopped.
  • You still have side effects from the earlier study that may be linked to its treatment.
  • Your current treatment is approved and its cost is covered in your country.
  • You are pregnant or breastfeeding.
  • You can become pregnant but are not using highly effective birth control or will not keep using it during treatment.
  • You are a sexually active male taking imatinib, nilotinib, bosutinib, or dasatinib and will not follow the drug's local birth control rules.
  • If switching to asciminib from bosutinib in study CABL001A2301 or from another TKI (a targeted cancer drug) in study CABL001A2202: you have grade 2 pancreas swelling without symptoms that has not cleared within 28 days; a heart rhythm measure called QTcF above 480 milliseconds or one that cannot be measured; or a severe side effect (grade 3 or 4) that has not improved to grade 2 or lower within 28 days before starting asciminib.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment: * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days * QTcF\>480msec or inability to determine QTc interval * 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 sites (6)

MI

NY

OR

TX

WI