Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT05201066
Eligibility Criteria:
Inclusion Criteria:
1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study.
2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment.
3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures.
5. Written informed consent obtained prior to enrolling in the roll-over study.
Exclusion Criteria:
1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol.
2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
3. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume).
4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation.
5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol.
6. Local access to commercially available sabatolimab for parent protocol indications.
Other protocol-defined Inclusion/Exclusion may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
99 Years
Study:
NCT05201066
Study Brief:
Protocol Section:
NCT05201066