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It is hypothesized that significantly more patients would prefer oral decitabine/cedazuridine to subcutaneous (SC) azacitidine (AZA) due to several factors, including improved treatment convenience, the reduced risk of nosocomial infections, and reduced treatment discomfort. However, this hypothesis has not been formally studied in a controlled setting. This study aims to address this evidence gap and evaluate patient, primary caregiver (carer), and clinician treatment preference between oral decitabine/cedazuridine and SC AZA in the treatment of adult patients with International Prognostic Scoring System-Revised (IPSS-R) intermediate, IPSS intermediate-2, or high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or low-blast (LB) acute myeloid leukemia (AML) and thereby lend further credibility to the clinical, economic, and patient value of oral decitabine/cedazuridine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBA | Active Comparator | Cycle 1: Oral decitabine/cedazuridine; Cycle 2: Subcutaneous azacitidine; Cycle 3: Subcutaneous azacitidine; Cycle 4: Oral decitabine/cedazuridine |
|
| BAAB | Active Comparator | Cycle 1: Subcutaneous azacitidine; Cycle 2: Oral decitabine/cedazuridine; Cycle 3: Oral decitabine/cedazuridine; Cycle 4: Subcutaneous azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous azacitidine | Drug | Subcutaneous azacitidine, 75mg/m2, 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the patient treatment preference in myelodysplasia questionnaire (pTPMQ) | Prior to initiation of Cycle 3 (each cycle is 28 days) | |
| Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the pTPMQ | Prior to initiation of Cycle 5 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of carers reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the carer treatment preference in myelodysplasia questionnaire (cTPMQ) | Prior to initiation of Cycle 3 (each cycle is 28 days) | |
| Proportion of carers reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the cTPMQ |
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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:
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:
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:
For Carers:
Carers are excluded from the study if any of the following criteria apply:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Anoop Enjeti | Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calvary Mater Newcastle | Newcastle | New South Wales | Australia | |||
| Pindara Private Hospital |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2026 | |
| Reset | Jan 29, 2026 |
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| Oral decitabine/cedazuridine |
| Drug |
Oral decitabine 35mg/cedazuridine 100mg, once daily, 5 days |
|
| Prior to initiation of Cycle 5 (each cycle is 28 days) |
| Proportion of clinicians reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the medical treatment preference in myelodysplasia questionnaire (mTPMQ) | Prior to initiation of Cycle 4 (each cycle is 28 days) |
| Proportion of clinicians reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the mTPMQ | End of Study (EOS) Day 28 |
| Proportion of clinicians choosing oral decitabine/cedazuridine vs subcutaneous azacitidine for continuation of treatment and reasons for the treatment choice based on the mTPMQ | Cycle 5, Day 1 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 1, Day 1 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 1, Day 1 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 3, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 3, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and Subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 4, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and Subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 4, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 5, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 5, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 6, Day 5 (each cycle is 28 days) |
| Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients | Cycle 6, Day 5 (each cycle is 28 days) |
| The difference in the incidence of treatment discontinuation and reasons for treatment discontinuation | Baseline (pre-intervention) through to study completion (up to 6 cycles of treatment where each cycle is 28 days) |
| Incidence and severity of adverse events upon study physician discretion. | Baseline (pre-intervention) through to study completion (up to 6 cycles of treatment where each cycle is 28 days) |
| Benowa |
| Queensland |
| Australia |
| Townsville Hospital | Townsville | Queensland | Australia |
| Adelaide Oncology and Haematology | North Adelaide | South Australia | Australia |
| Grampian Health (Ballarat Base Hospital) | Ballarat Central | Victoria | Australia |
| Latrobe Regional Hospital | Traralgon | Victoria | Australia |
| Christchurch Hospital | Christchurch | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Auckland City Hospital | Grafton | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |
| North Shore Hospital (Waitemata District Health Board) | Takapuna | New Zealand |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2026 | Jan 29, 2026 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000723076 | decitabine and cedazuridine drug combination |
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