Phase
Condition
Leukemia
Myelodysplastic Syndromes (Mds)
White Cell Disorders
Treatment
Subcutaneous azacitidine
Oral decitabine/cedazuridine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, LBAML or CMML (with symptoms), as confirmed by recent full blood examination, bonemarrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDSpatients 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 aselectronic 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, LBAML or CMML (with symptoms), as confirmed by recent full blood examination, bonemarrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDSpatients 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 aselectronic 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
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 oraldecitabine/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 ofstandard of care (SOC).
Receipt of any immunotherapy, any conventional or investigational systemicanti-cancer therapy within 5 half-lives of the drug, or within 4 weeks prior to thefirst dose of study treatment (whichever is longer).
Any medical, psychological, social, or other condition which in the view of theInvestigator is likely to interfere with the study, compliance, or put the patientat risk.
Participants who are not fluent in English, or who cannot read or write in Englishwill 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).
Study Design
Connect with a study center
Calvary Mater Newcastle
Newcastle, New South Wales
AustraliaSite Not Available
Pindara Private Hospital
Benowa, Queensland
AustraliaSite Not Available
Townsville Hospital
Townsville, Queensland
AustraliaSite Not Available
Adelaide Oncology and Haematology
North Adelaide, South Australia
AustraliaSite Not Available
Grampian Health (Ballarat Base Hospital)
Ballarat Central, Victoria
AustraliaSite Not Available
Latrobe Regional Hospital
Traralgon, Victoria
AustraliaSite Not Available
Christchurch Hospital
Christchurch,
New ZealandSite Not Available
Dunedin Hospital
Dunedin,
New ZealandSite Not Available
Auckland City Hospital
Grafton,
New ZealandSite Not Available
Waikato Hospital
Hamilton,
New ZealandSite Not Available
North Shore Hospital (Waitemata District Health Board)
Takapuna,
New ZealandSite Not Available

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