NCT07663864RecruitingPhase 1/2
Luspatercept for CIA in AML
Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 6 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07663864
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Jun 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 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
- Concurrent myelofibrosis
- History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
Other illness
- Heart function \< grade 2
- Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection
- History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
Lab values
- Renal function: creatinine clearance \< 30 ml/min
- Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal
Other
- t-AML/sAML
- Patients unresponsive to red blood cell transfusions
- Pregnant or breastfeeding women
- Patients deemed unsuitable for enrollment by the investigators
Who the study is looking for
- De novo AML patients;
- Age ≥ 18 years and ≤ 60 years;
- AML with ELN2022-low risk
- Received 1-3 cycles of HDAC consolidation therapy
- HGB 60-90 G/L
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- Life expectancy ≥ 3 months;
- Signed informed consent and able to understand and comply with the procedures required by this protocol.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Hematology, Guangdong Second Provincial General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.