Luspatercept for CIA in AML
ConditionChemotherapy-inducing Anemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGuangdong Second Provincial General Hospital
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.
Eligibility criteria
Qualifiers
De novo AML patients;
Age ≥ 18 years and ≤ 60 years;
AML with ELN2022-low risk
Received 1-3 cycles of HDAC consolidation therapy
Disqualifiers
t-AML/sAML
Concurrent myelofibrosis
Patients unresponsive to red blood cell transfusions
Heart function < grade 2
Trial design
Treatments tested in this trial
- Luspatercept Injectable Product
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Guangdong Second Provincial General Hospital
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Guangzhou First People's Hospital
Collaborator
Affiliated Hospital of Guangdong Medical University
Collaborator
Guangzhou 8th People's Hospital
Collaborator
Source ClinicalTrials.gov