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

Last updated: March 17, 2025
Sponsor: Otsuka Australia Pharmaceutical Pty Ltd
Overall Status: Active - Not Recruiting

Phase

3

Condition

Leukemia

Myelodysplastic Syndromes (Mds)

White Cell Disorders

Treatment

Subcutaneous azacitidine

Oral decitabine/cedazuridine

Clinical Study ID

NCT05883956
393-419-00041
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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, LBAML or CMML (with symptoms), as confirmed by recent full blood examination, bonemarrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDSpatients 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 aselectronic questionnaires on digital devices) over the following 4 months.

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, LBAML or CMML (with symptoms), as confirmed by recent full blood examination, bonemarrow biopsy, and cytogenetic testing. NOTE: IPSS-R defined intermediate MDSpatients 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 aselectronic questionnaires on digital devices) over the following 4 months.

  • Patient must be able to identify a carer to participate in completing the cTPMQ.

For Carers:

• Primary carer of a patient meeting all of the inclusion criteria (ie, a patient who meets criteria defined above).

For Clinicians:

• Clinician treating patients meeting all of the inclusion criteria (ie, treats patients who meet criteria defined above).

Exclusion

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 oraldecitabine/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 ofstandard of care (SOC).

  • Receipt of any immunotherapy, any conventional or investigational systemicanti-cancer therapy within 5 half-lives of the drug, or within 4 weeks prior to thefirst dose of study treatment (whichever is longer).

  • Any medical, psychological, social, or other condition which in the view of theInvestigator is likely to interfere with the study, compliance, or put the patientat risk.

  • Participants who are not fluent in English, or who cannot read or write in Englishwill be excluded from the study.

For Carers:

Carers are excluded from the study if any of the following criteria apply:

  • They are a carer of a patient who meets any of the exclusion criteria listed above.

  • They are a relative of an employee of the investigational clinic or sponsor (e.g.Investigator, study coordinator)

For Clinicians:

• Clinicians will be excluded from participating in the study if they are a relative of an employee of the investigational clinic or sponsor (e.g. Investigator, Study Coordinator).

Study Design

Total Participants: 13
Treatment Group(s): 2
Primary Treatment: Subcutaneous azacitidine
Phase: 3
Study Start date:
December 20, 2023
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Calvary Mater Newcastle

    Newcastle, New South Wales
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland
    Australia

    Site Not Available

  • Townsville Hospital

    Townsville, Queensland
    Australia

    Site Not Available

  • Adelaide Oncology and Haematology

    North Adelaide, South Australia
    Australia

    Site Not Available

  • Grampian Health (Ballarat Base Hospital)

    Ballarat Central, Victoria
    Australia

    Site Not Available

  • Latrobe Regional Hospital

    Traralgon, Victoria
    Australia

    Site Not Available

  • Christchurch Hospital

    Christchurch,
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin,
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Grafton,
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton,
    New Zealand

    Site Not Available

  • North Shore Hospital (Waitemata District Health Board)

    Takapuna,
    New Zealand

    Site Not Available

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