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RecruitingLast updated: 8 May 2024

PREFER-HMA: This study is comparing treatment preference between an oral drug or an injection in adults with myelodysplastic syndromes, acute myeloid leukaemia, or chronic myelomonocytic leukaemiaA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. Both arms will receive the same treatments, they will just receive them in a different sequential order.

In Arm A, participants will receive:

  • Cycle 1: Oral decitabine/cedazuridine
  • Cycle 2: An injection under the skin (subcutaneous) of azacitidine
  • Cycle 3: Subcutaenous azacitidine
  • Cycle 4: Oral decitabine/cedazuridine

In Arm B, participants will receive:

  • Cycle 1: Subcutaenous azacitidine
  • Cycle 2: Oral decitabine/cedazuridine
  • Cycle 3: Oral decitabine/cedazuridine
  • Cycle 4: Subcutaenous azacitidine

 

Conditions

This trial is treating patients with IPSS R Intermediate Myelodysplastic Syndrome, Low Blast Acute Myeloid Leukaemia, IPSS Intermediate-2 or High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

PREFER-HMA

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Otsuka Australia Pharmaceutical Pty Ltd

Scientific 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

Eligibility

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, 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

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).

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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