Status:
NOT_YET_RECRUITING
AZA+Lus VS AZA Monotherapy in HR-MDS
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Higher-risk Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort...
Detailed Description
The hypomethylating agents (HMA) azacitidine (AZA) and decitabine (DEC) have been shown to improve survival and delay disease progression in patients with high-risk MDS. They are recommended by the NC...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Diagnosed as higher-risk MDS (IPSS intermediate-2/high-risk, or IPSS-R \>3.5, or IPSS-M moderate high-, high-, very high-risk)
- Untreated patients
- Liver and kidney function less than 2 times of upper limit of normal
- ECOG≤2 and expected survival more than 6 months
- Informed consent signed
Exclusion
- With active infection
- Other malignant tumors
- Obvious abnormal liver and kidney function, or abnormal function of other organs
- Combined with myelofibrosis
- Have undergone bone marrow transplantation
- Pregnant or lactating women, or men who have recent reproductive needs
- Allergic to azacytidine, Rotercept or excipients
- History of polysorbate 80 allergy
- Refuse to sign informed consent
- Researchers consider it inappropriate to participate in the experiment
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06927232
Start Date
April 1 2025
End Date
January 31 2027
Last Update
April 15 2025
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