Luspatercept for CIA in AML
Recruiting
Phase 1
Phase 2
Interventional Study
Chemotherapy-inducing Anemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Guangdong Second Provincial General Hospital · Other
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About This Trial
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.
Trial Locations
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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 …
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