NCT07663864 Luspatercept for CIA in AML
| NCT ID | NCT07663864 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Guangdong Second Provincial General Hospital |
| Condition | Chemotherapy-inducing Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07663864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Chemotherapy-inducing Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07663864 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07663864 currently recruiting?
Yes, NCT07663864 is actively recruiting participants. Contact the research team at yugpp@163.com for enrollment information.
Where is the NCT07663864 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07663864 clinical trial?
NCT07663864 is sponsored by Guangdong Second Provincial General Hospital. The trial plans to enroll 40 participants.