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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT05883956
Eligibility Criteria:
Inclusion Criteria:
For Patients:
Patients are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to study treatment administration:
* Patients must be 18 years of age or older.
* IPSS-R defined intermediate MDS, IPSS defined intermediate 2 or high-risk MDS, LB AML or CMML (with symptoms), as confirmed by recent full blood examination, bone marrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDS patients are limited to less than 50% of enrolled patients.
* Life expectancy of at least 6 months.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 inclusive.
* Patient must be able to co-operate and complete tasks (including tasks such as electronic questionnaires on digital devices) over the following 4 months.
Inclusion Criteria:
For Patients:
Patients are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to study treatment administration:
* Patients must be 18 years of age or older.
* IPSS-R defined intermediate MDS, IPSS defined intermediate 2 or high-risk MDS, LB AML or CMML (with symptoms), as confirmed by recent full blood examination, bone marrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDS patients are limited to less than 50% of enrolled patients.
* Life expectancy of at least 6 months.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 inclusive.
* Patient must be able to co-operate and complete tasks (including tasks such as electronic questionnaires on digital devices) over the following 4 months.
* Patient must be able to identify a carer to participate in completing the cTPMQ.
For Carers:
• Primary carer of a patient meeting all of the inclusion criteria (ie, a patient who meets criteria defined above).
For Clinicians:
• Clinician treating patients meeting all of the inclusion criteria (ie, treats patients who meet criteria defined above).
Exclusion Criteria:
For Patients:
Patients are excluded from the study if any of the following criteria apply:
* Patients with known hypersensitivity to the study treatments oral decitabine/cedazuridine or azacitidine.
* Patients with advanced malignant hepatic tumors.
* Patients with severe renal impairment (creatinine clearance \<30 mL/min).
* Patients who have received hypomethylating agents (HMA) previously.
* Patients who are receiving lenalidomide or are receiving other therapies outside of standard of care (SOC).
* Receipt of any immunotherapy, any conventional or investigational systemic anti-cancer therapy within 5 half-lives of the drug, or within 4 weeks prior to the first dose of study treatment (whichever is longer).
* Any medical, psychological, social, or other condition which in the view of the Investigator is likely to interfere with the study, compliance, or put the patient at risk.
* Participants who are not fluent in English, or who cannot read or write in English will be excluded from the study.
For Carers:
Carers are excluded from the study if any of the following criteria apply:
* They are a carer of a patient who meets any of the exclusion criteria listed above.
* They are a relative of an employee of the investigational clinic or sponsor (e.g. Investigator, study coordinator)
For Clinicians:
• Clinicians will be excluded from participating in the study if they are a relative of an employee of the investigational clinic or sponsor (e.g. Investigator, Study Coordinator).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05883956
Study Brief:
Protocol Section:
NCT05883956