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Luspatercept for CIA in AML

NCT07663864 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-23

No results posted yet for this 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.

Conditions

  • Chemotherapy-inducing Anemia

Interventions

DRUG

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER

  • Guangzhou 8th People's Hospital

    collaborator OTHER

  • Guangdong Second Provincial General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663864 on ClinicalTrials.gov