Luspatercept for CIA in AML

NCT07663864 | Recruiting Phase 1

• 1 other identifier: GD2H-2026-483
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-inducing Anemia

Keywords

Acute myeloid leukemia; Chemotherapy; Anemia; Luspatercept

Outcome Measures

Primary Outcomes (1)

• Time of 50% increase in hemoglobin levels from baseline

  The time of hemoglobin levels increasing 50% from baseline

  Days 1-28 post chemotherapy

Secondary Outcomes (5)

• Duration of HGB < 60 G/L during the treatment course (1-28 days)

  Days 1-28 after AML chemistry treatment

• Incidence of HGB < 60 G/L during the treatment course (days 1-28)

  Days 1-28 after chemotherapy

• Red blood cell transfusion volume

  Days 1-28 after AML chemistry treamtment

• MRD negative rate

  6 months after AML chemistry treamtment

• Anemia recurrence rate

  12 months after AML chemistry treamtment

Other Outcomes (1)

• Number of people experiencing treatment-related adverse events

  Days 1-28 after Luspatercept treatment

Study Arms (1)

Rotesip treatment group

EXPERIMENTAL

Patients were screened and enrolled in the treatment group to evaluate the efficacy and safety of rotezipeptide in the treatment of chemotherapy-inducing anemia in AML.

Drug: Luspatercept Injectable Product

Interventions

Luspatercept Injectable Product DRUG

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.

Rotesip treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• De novo AML patients;
• Age ≥ 18 years and ≤ 60 years;
• AML with ELN2022-low risk
• Received 1-3 cycles of HDAC consolidation therapy
• HGB 60-90 G/L
• Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
• Life expectancy ≥ 3 months;
• Signed informed consent and able to understand and comply with the procedures required by this protocol.

You may not qualify if:

• t-AML/sAML
• Concurrent myelofibrosis
• Patients unresponsive to red blood cell transfusions
• Heart function \< grade 2
• Renal function: creatinine clearance \< 30 ml/min
• Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal
• Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
• History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
• 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
• History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
• Pregnant or breastfeeding women
• Patients deemed unsuitable for enrollment by the investigators

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital: lead
• 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

Study Sites (1)

Department of Hematology, Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Guopan Yu, PhD

CONTACT

+8615876559968; yugpp@163.com

Tianmiao Yu, Master

CONTACT

yutm96@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Patients were screened and enrolled in the treatment group to evaluate the efficacy of rotezipeptide in the treatment of chemotherapy-inducing anemia (CIA) in AML. 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.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)