Luspatercept for CIA in AML

June 17, 2026 updated by: Qing Zhang, Guangdong Second Provincial General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied. Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy. The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders. Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy. Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guopan Yu, PhD
  • Phone Number: +8615876559968
  • Email: yugpp@163.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Department of Hematology, Guangdong Second Provincial General Hospital
        • Contact:
          • Guopan Yu, PhD
          • Phone Number: +8615876559968
          • Email: yugpp@163.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 and able to understand and comply with the procedures required by this protocol.

Exclusion Criteria:

  1. t-AML/sAML
  2. Concurrent myelofibrosis
  3. Patients unresponsive to red blood cell transfusions
  4. Heart function < grade 2
  5. Renal function: creatinine clearance < 30 ml/min
  6. Liver function: ALTd > 5 times normal, bilirubin > 3 times normal
  7. Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
  8. History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
  9. 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
  10. History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
  11. Pregnant or breastfeeding women
  12. Patients deemed unsuitable for enrollment by the investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotesip treatment group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of 50% increase in hemoglobin levels from baseline
Time Frame: Days 1-28 post chemotherapy
The time of hemoglobin levels increasing 50% from baseline
Days 1-28 post chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of HGB < 60 G/L during the treatment course (1-28 days)
Time Frame: Days 1-28 after AML chemistry treatment
The duration of HGB < 60 G/L during this consolidation treatment course (days 1-28);
Days 1-28 after AML chemistry treatment
Incidence of HGB < 60 G/L during the treatment course (days 1-28)
Time Frame: Days 1-28 after chemotherapy
The incidence of HGB < 60 G/L during this consolidation treatment course (days 1-28);
Days 1-28 after chemotherapy
Red blood cell transfusion volume
Time Frame: Days 1-28 after AML chemistry treamtment
Red blood cell transfusion volume during this consolidation treatment course (days 1-28);
Days 1-28 after AML chemistry treamtment
MRD negative rate
Time Frame: 6 months after AML chemistry treamtment
MRD negative rate within 6 months;
6 months after AML chemistry treamtment
Anemia recurrence rate
Time Frame: 12 months after AML chemistry treamtment
Relapse rate 12 months after chemotherapy;
12 months after AML chemistry treamtment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of people experiencing treatment-related adverse events
Time Frame: Days 1-28 after Luspatercept treatment
According to the CTCAE v5.0 assessment, the number of people who experienced treatment-related adverse events included both hematological and non-hematological toxicities.
Days 1-28 after Luspatercept treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Second Provincial General Hospital

Collaborators

Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou 8th People's Hospital
First Affiliated Hospital of Guangxi Medical University
Affiliated Hospital of Guangdong Medical University
Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GD2H-2026-483

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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