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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

NCT05883956•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Patients:
•Patients are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to study treatment administration:
•Patients must be 18 years of age or older.
•IPSS-R defined intermediate MDS, IPSS defined intermediate 2 or high-risk MDS, LB AML or CMML (with symptoms), as confirmed by recent full blood examination, bone marrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDS patients are limited to less than 50% of enrolled patients.
•Life expectancy of at least 6 months.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 inclusive.
•Patient must be able to co-operate and complete tasks (including tasks such as electronic questionnaires on digital devices) over the following 4 months.
•For Patients:
•Patients are eligible to be included in the study only if all of the following criteria apply at any time starting from Screening up to Day 1 prior to study treatment administration:
•Patients must be 18 years of age or older.
+7 more criteria

Exclusion Criteria

•For Patients:
•Patients are excluded from the study if any of the following criteria apply:
•Patients with known hypersensitivity to the study treatments oral decitabine/cedazuridine or azacitidine.
•Patients with advanced malignant hepatic tumors.
•Patients with severe renal impairment (creatinine clearance \<30 mL/min).
•Patients who have received hypomethylating agents (HMA) previously.
•Patients who are receiving lenalidomide or are receiving other therapies outside of standard of care (SOC).
•Receipt of any immunotherapy, any conventional or investigational systemic anti-cancer therapy within 5 half-lives of the drug, or within 4 weeks prior to the first dose of study treatment (whichever is longer).
•Any medical, psychological, social, or other condition which in the view of the Investigator is likely to interfere with the study, compliance, or put the patient at risk.
•Participants who are not fluent in English, or who cannot read or write in English will be excluded from the study.
+5 more criteria

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

Key Dates

Start Date

December 20, 2023

Primary Completion Date

December 6, 2024

Completion Date

May 1, 2025

Last Updated

March 20, 2025

Enrollment

ACTUAL participants

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicPatient Preference

Interventions

Subcutaneous azacitidine

DRUG

Oral decitabine/cedazuridine

DRUG

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222

Leukemia, Myeloid, Acute

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RECRUITINGPHASE1

Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

NCT07270978

Acute Myeloid LeukemiaMyelodysplastic Syndromes+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

Venetoclax Basket Trial for High Risk Hematologic Malignancies

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment