Trial Title:
A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia
NCT ID:
NCT05883956
Condition:
Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Chronic
Patient Preference
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Syndrome
Azacitidine
Decitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Subcutaneous azacitidine
Description:
Subcutaneous azacitidine, 75mg/m2, 7 days
Arm group label:
ABBA
Arm group label:
BAAB
Intervention type:
Drug
Intervention name:
Oral decitabine/cedazuridine
Description:
Oral decitabine 35mg/cedazuridine 100mg, once daily, 5 days
Arm group label:
ABBA
Arm group label:
BAAB
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.
Criteria for eligibility:
Criteria:
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.
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.
- 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 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.
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Calvary Mater Newcastle
Address:
City:
Newcastle
Country:
Australia
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Country:
Australia
Facility:
Name:
Townsville Hospital
Address:
City:
Townsville
Country:
Australia
Facility:
Name:
Adelaide Oncology and Haematology
Address:
City:
North Adelaide
Country:
Australia
Facility:
Name:
Grampian Health (Ballarat Base Hospital)
Address:
City:
Ballarat Central
Country:
Australia
Facility:
Name:
Latrobe Regional Hospital
Address:
City:
Traralgon
Country:
Australia
Facility:
Name:
Christchurch Hospital
Address:
City:
Christchurch
Country:
New Zealand
Facility:
Name:
Dunedin Hospital
Address:
City:
Dunedin
Country:
New Zealand
Facility:
Name:
Auckland City Hospital
Address:
City:
Grafton
Country:
New Zealand
Facility:
Name:
Waikato Hospital
Address:
City:
Hamilton
Country:
New Zealand
Facility:
Name:
North Shore Hospital (Waitemata District Health Board)
Address:
City:
Takapuna
Country:
New Zealand
Start date:
December 20, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Otsuka Australia Pharmaceutical Pty Ltd
Agency class:
Industry
Source:
Otsuka Australia Pharmaceutical Pty Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05883956
