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A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia
Sponsor: Otsuka Australia Pharmaceutical Pty Ltd
Summary
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.
Official title: A Phase 3b, Randomized, Open-Label, Double Crossover Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Adult Patients With IPSS R Intermediate Myelodysplastic Syndrome, Low Blast Acute Myeloid Leukemia, IPSS Intermediate-2 or High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2023-12-20
Completion Date
2025-05
Last Updated
2025-03-20
Healthy Volunteers
No
Conditions
Interventions
Subcutaneous azacitidine
Subcutaneous azacitidine, 75mg/m2, 7 days
Oral decitabine/cedazuridine
Oral decitabine 35mg/cedazuridine 100mg, once daily, 5 days
Locations (11)
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Pindara Private Hospital
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