NCT06927232Not yet recruitingPhase 3
AZA+Lus VS AZA Monotherapy in HR-MDS
Azacitidine Plus Luspatercept Versus Azacitidine Monotherapy in Higher-risk Myelodysplastic Neoplasms: a Randomized Prospective Study
Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- Apr 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT06927232
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 86
- From Apr 2025 to the primary completion date, 31 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have undergone bone marrow transplantation
Other illness
- With active infection
- Other malignant tumors
- Allergic to azacytidine, Rotercept or excipients
- History of polysorbate 80 allergy
Other
- Obvious abnormal liver and kidney function, or abnormal function of other organs
- Combined with myelofibrosis
- Pregnant or lactating women, or men who have recent reproductive needs
- Refuse to sign informed consent
- Researchers consider it inappropriate to participate in the experiment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.