A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia

Korábbi kezelés

• 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).

Más betegség

• Patients with known hypersensitivity to the study treatments oral decitabine/cedazuridine or azacitidine.
• Patients with advanced malignant hepatic tumors.
• 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.

Laborértékek

• Patients with severe renal impairment (creatinine clearance <30 mL/min).

Egyéb

• For Patients:
• Patients are excluded from the study if any of the following criteria apply:
• 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).

• 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.
• 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).