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ACTIVE NOT RECRUITING
NCT05883956
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Subcutaneous azacitidine

Subcutaneous azacitidine, 75mg/m2, 7 days

DRUG

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