Myelodysplastic SyndromesPhase 3PREFER-HMANCT05883956

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 3 study testing Subcutaneous azacitidine and Oral decitabine/cedazuridine in people with Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Otsuka Australia Pharmaceutical Pty Ltd at 11 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic
What is being tested?: Subcutaneous azacitidine and Oral decitabine/cedazuridine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 11 sitesin 2 countries
Study dates: 20 Dec 2023to May 2025
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 19Show fewer

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.
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.
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).

Who cannot join

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.

Show all 16Show fewer

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.
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).

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

Australia6 sites

Grampian Health (Ballarat Base Hospital)
Ballarat Central, Victoria
Pindara Private Hospital
Benowa, Queensland
Calvary Mater Newcastle
Newcastle, New South Wales
Adelaide Oncology and Haematology
North Adelaide, South Australia
Townsville Hospital
Townsville, Queensland
Latrobe Regional Hospital
Traralgon, Victoria

Other trials in Australia

New Zealand5 sites

Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Auckland City Hospital
Grafton
Waikato Hospital
Hamilton
North Shore Hospital (Waitemata District Health Board)
Takapuna

Other trials in New Zealand

About this study

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

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
Being tested: Subcutaneous azacitidine, Oral decitabine/cedazuridine
Medical subject headings: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subcutaneous azacitidineDrug
Subcutaneous azacitidine, 75mg/m2, 7 days
Oral decitabine/cedazuridineDrug
Oral decitabine 35mg/cedazuridine 100mg, once daily, 5 days

Study groups in NCT05883956
Study group	Role	What they receive
ABBA	Active comparator	Cycle 1: Oral decitabine/cedazuridine; Cycle 2: Subcutaneous azacitidine; Cycle 3: Subcutaneous azacitidine; Cycle 4: Oral decitabine/cedazuridine Receives: Drug: Subcutaneous azacitidine; Drug: Oral decitabine/cedazuridine
BAAB	Active comparator	Cycle 1: Subcutaneous azacitidine; Cycle 2: Oral decitabine/cedazuridine; Cycle 3: Oral decitabine/cedazuridine; Cycle 4: Subcutaneous azacitidine Receives: Drug: Subcutaneous azacitidine; Drug: Oral decitabine/cedazuridine

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the patient treatment preference in myelodysplasia questionnaire (pTPMQ)
Measured: Prior to initiation of Cycle 3 (each cycle is 28 days)
Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the pTPMQ
Measured: Prior to initiation of Cycle 5 (each cycle is 28 days)

Secondary outcomes (17)

Proportion of carers reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the carer treatment preference in myelodysplasia questionnaire (cTPMQ)
Measured: Prior to initiation of Cycle 3 (each cycle is 28 days)
Proportion of carers reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the cTPMQ
Measured: Prior to initiation of Cycle 5 (each cycle is 28 days)
Proportion of clinicians reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the medical treatment preference in myelodysplasia questionnaire (mTPMQ)
Measured: Prior to initiation of Cycle 4 (each cycle is 28 days)
Proportion of clinicians reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the mTPMQ
Measured: End of Study (EOS) Day 28
Proportion of clinicians choosing oral decitabine/cedazuridine vs subcutaneous azacitidine for continuation of treatment and reasons for the treatment choice based on the mTPMQ
Measured: Cycle 5, Day 1 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 1, Day 1 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 1, Day 1 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 3, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 3, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and Subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 4, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and Subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 4, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 5, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 5, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 6, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Measured: Cycle 6, Day 5 (each cycle is 28 days)
The difference in the incidence of treatment discontinuation and reasons for treatment discontinuation
Measured: Baseline (pre-intervention) through to study completion (up to 6 cycles of treatment where each cycle is 28 days)
Incidence and severity of adverse events upon study physician discretion.
Measured: Baseline (pre-intervention) through to study completion (up to 6 cycles of treatment where each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 2023May 2025

First posted1 Jun 2023
Study start20 Dec 2023
Primary completion6 Dec 2024
Study completionMay 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05883956
Sponsor's protocol ID: 393-419-00041
Acronym: PREFER-HMA
Status last verified: Mar 2025
First submitted: 25 Apr 2023
Last updated: 20 Mar 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05883956
Acronym / sponsor ID: PREFER-HMA / 393-419-00041
Conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Patient Preference
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 13 participants (actual)
Lead sponsor: Otsuka Australia Pharmaceutical Pty LtdIndustry (pharma, biotech, devices)
Study start: 20 Dec 2023 (actual)
Primary completion: 6 Dec 2024 (actual)
Study completion: May 2025 (estimated)
First posted: 1 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ABBA	Active comparator	Drug: Subcutaneous azacitidine, Drug: Oral decitabine/cedazuridineCycle 1: Oral decitabine/cedazuridine; Cycle 2: Subcutaneous azacitidine; Cycle 3: Subcutaneous azacitidine; Cycle 4: Oral decitabine/cedazuridine
BAAB	Active comparator	Drug: Subcutaneous azacitidine, Drug: Oral decitabine/cedazuridineCycle 1: Subcutaneous azacitidine; Cycle 2: Oral decitabine/cedazuridine; Cycle 3: Oral decitabine/cedazuridine; Cycle 4: Subcutaneous azacitidine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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.

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Subcutaneous azacitidineSubcutaneous azacitidine, 75mg/m2, 7 days	Drug	ABBA, BAAB
Oral decitabine/cedazuridineOral decitabine 35mg/cedazuridine 100mg, once daily, 5 days	Drug	ABBA, BAAB

Primary outcome

Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the patient treatment preference in myelodysplasia questionnaire (pTPMQ)
Time frame: Prior to initiation of Cycle 3 (each cycle is 28 days)
Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the pTPMQ
Time frame: Prior to initiation of Cycle 5 (each cycle is 28 days)

17 secondary outcomes

Proportion of carers reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the carer treatment preference in myelodysplasia questionnaire (cTPMQ)
Time frame: Prior to initiation of Cycle 3 (each cycle is 28 days)
Proportion of carers reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the cTPMQ
Time frame: Prior to initiation of Cycle 5 (each cycle is 28 days)
Proportion of clinicians reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the medical treatment preference in myelodysplasia questionnaire (mTPMQ)
Time frame: Prior to initiation of Cycle 4 (each cycle is 28 days)
Proportion of clinicians reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the mTPMQ
Time frame: End of Study (EOS) Day 28
Proportion of clinicians choosing oral decitabine/cedazuridine vs subcutaneous azacitidine for continuation of treatment and reasons for the treatment choice based on the mTPMQ
Time frame: Cycle 5, Day 1 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 1, Day 1 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 1, Day 1 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 3, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 3, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and Subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 4, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and Subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 4, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 5, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 5, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EQ-5D-5L in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 6, Day 5 (each cycle is 28 days)
Difference in quality of life between oral decitabine/cedazuridine and subcutaneous azacitidine as assessed using the EORTC QLQ-C30 in Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myeloid Leukemia patients
Time frame: Cycle 6, Day 5 (each cycle is 28 days)
The difference in the incidence of treatment discontinuation and reasons for treatment discontinuation
Time frame: Baseline (pre-intervention) through to study completion (up to 6 cycles of treatment where each cycle is 28 days)
Incidence and severity of adverse events upon study physician discretion.
Time frame: Baseline (pre-intervention) through to study completion (up to 6 cycles of treatment where each cycle is 28 days)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anoop Enjeti principal investigator

Calvary Mater Newcastle, Edith Street, Waratah, NSW 2298 Australia

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients reporting preference for oral decitabine/cedazuridine vs subcutaneous azacitidine on the patient treatment preference in myelodysplasia questionnaire (pTPMQ) (time frame: Prior to initiation of Cycle 3 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05883956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.