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RECRUITING
NCT07663864
PHASE1/PHASE2

Luspatercept for CIA in AML

Sponsor: Guangdong Second Provincial General Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-06-01

Completion Date

2027-05-31

Last Updated

2026-06-23

Healthy Volunteers

No

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.

Locations (1)

Department of Hematology, Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China