Luspatercept Injectable Product: First, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg/kg at the day 1 versus day 10 post chemotherapy. Each groups were analyzed to enroll et least 10 patients. Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. De novo AML patients;
2. Age ≥ 18 years and ≤ 60 years;
3. AML with ELN2022-low risk
4. Received 1-3 cycles of HDAC consolidation therapy
5. HGB 60-90 G/L
6. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
7. Life expectancy ≥ 3 months;
8. Signed informed consent and able to understand and comply with the procedures required by this protocol.
Exclusion Criteria:
1. t-AML/sAML
2. Concurrent myelofibrosis
3. Patients unresponsive to red blood cell transfusions
4. Heart function \< grade 2
5. Renal function: creatinine clearance \< 30 ml/min
6. Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal
7. Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
8. History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
9. 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
10. History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
11. Pregnant or breastfeeding women
12. Patients deemed unsuitable for enrollment by the investigators
Primary outcome measure(s)
Time of 50% increase in hemoglobin levels from baseline — Days 1-28 post chemotherapy The time of hemoglobin levels increasing 50% from baseline
Trial sites (1)
Facility
City
Region
Status
Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou
Guangdong
Recruiting
More Guangdong Second Provincial General Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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