Trials / Active Not Recruiting
Active Not RecruitingNCT05883956
A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Otsuka Australia Pharmaceutical Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Myelodysplastic Syndromes
- Leukemia, Myeloid, Acute
- Leukemia, Myelomonocytic, Chronic
- Patient Preference
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Subcutaneous azacitidine | Subcutaneous azacitidine, 75mg/m2, 7 days |
| DRUG | Oral decitabine/cedazuridine | Oral decitabine 35mg/cedazuridine 100mg, once daily, 5 days |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2024-12-06
- Completion
- 2025-05-01
- First posted
- 2023-06-01
- Last updated
- 2025-03-20
Locations
11 sites across 2 countries: Australia, New Zealand
Source: ClinicalTrials.gov record NCT05883956. Inclusion in this directory is not an endorsement.