drugset / Trial / NCT05883956

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

NCT05883956

Phase 3 Active not recruiting 13 enrolled Otsuka Australia Pharmaceutical Pty Ltd
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2023-12-20
Primary completion
2024-12-06
Completion
2025-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Comparator Cedazuridine Small molecule 100 mg Oral
Comparator Decitabine Small molecule 35 mg Oral