Clinical trial · Interventional
AZA+Lus VS AZA Monotherapy in HR-MDS
Azacitidine Plus Luspatercept Versus Azacitidine Monotherapy in Higher-risk Myelodysplastic Neoplasms: a Randomized Prospective Study
NCT06927232CI-TRIAL-00088553not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Higher-risk Myelodysplastic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine (AZA) | Drug | Azacitidine | ALIAS |
| Luspatercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Azacitidine+Luspatercept
- interventionNames
- Drug: Azacitidine (AZA)
- Drug: Luspatercept
- type
- ACTIVE_COMPARATOR
- label
- Azacitidine
- interventionNames
- Drug: Azacitidine (AZA)
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 3 months, 6 months
Secondary outcomes (6)
- measure
- complete response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.