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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

Study acronym: PREFER-HMA
StatusActive, Not Recruiting
PhasePhase 3
Started2023-12-20
View on ClinicalTrials.gov ↗

Amendment history

2025-03-17
Study Status v6
Primary completion dateestimated 2025-01→confirmed 2024-12-06
2024-06-04
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-04→2025-01
Enrollment targetestimated 42→confirmed 13
Study sitesdetails revised at 11 of 11 sites
2024-03-12
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-12-20
Study sitesdetails revised at 11 of 11 sites
2023-10-30
Study Status v3
Start date2023-09→2023-11
2023-09-11
Study Identification, Study Status v2
Primary completion date2025-03→2025-04
Completion date2025-04→2025-05
Start date2023-08→2023-09
2023-08-22
Study Status, Contacts/Locations v1
Primary completion date2024-08→2025-03
Start date2023-07→2023-08
Study sites1→11
2023-05-29
Original filing
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.
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