Clinical Trial

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

Study acronym: PREFER-HMA
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-05-29; most recent amendment 2025-03-17.
Status change: Recruiting → Active, Not Recruiting 2024-06-04
Status change: Not Yet Recruiting → Recruiting 2024-03-12
Trial Details
NCT Number NCT05883956
Lead Sponsor Otsuka Australia Pharmaceutical Pty Ltd
Conditions Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Patient Preference
Enrollment 13 participants
Start Date 2023-12-20
Primary Completion 2024-12-06 (estimated)
Study Completion 2025-05 (estimated)
Updated on ClinicalTrials.gov 2025-03-20