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Chemotherapy-inducing AnemiaPhase 1/2NCT07663864

Luspatercept for CIA in AML

A Phase 1/2 study testing Luspatercept Injectable Product in people with Chemotherapy-inducing Anemia, run by Guangdong Second Provincial General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chemotherapy-inducing Anemia
What is being tested?
Luspatercept Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jun 2026to 31 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guopan Yu, PhD contact

+8615876559968

yugpp@163.com

Tianmiao Yu, Master contact

yutm96@163.com

China1 site, 1 recruiting

  • Department of Hematology, Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong

    Guopan Yu, PhD, +8615876559968, yugpp@163.com

    Tianmiao Yu, Master, yutm96@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Luspatercept Injectable Product
Keywords
Acute myeloid leukemia, Chemotherapy, Anemia, Luspatercept
Medical subject headings
Leukemia, Myeloid, Acute, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Luspatercept Injectable ProductDrug

    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 groups in NCT07663864
Study groupRoleWhat they receive
Rotesip treatment groupExperimentalPatients 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.
Receives: Drug: Luspatercept Injectable Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of 50% increase in hemoglobin levels from baseline

    The time of hemoglobin levels increasing 50% from baseline

    Measured: Days 1-28 post chemotherapy

Secondary outcomes (5)

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

    The duration of HGB < 60 G/L during this consolidation treatment course (days 1-28);

    Measured: Days 1-28 after AML chemistry treatment

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

    The incidence of HGB < 60 G/L during this consolidation treatment course (days 1-28);

    Measured: Days 1-28 after chemotherapy

  3. Red blood cell transfusion volume

    Red blood cell transfusion volume during this consolidation treatment course (days 1-28);

    Measured: Days 1-28 after AML chemistry treamtment

  4. MRD negative rate

    MRD negative rate within 6 months;

    Measured: 6 months after AML chemistry treamtment

  5. Anemia recurrence rate

    Relapse rate 12 months after chemotherapy;

    Measured: 12 months after AML chemistry treamtment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663864
Sponsor's protocol ID
GD2H-2026-483
Status last verified
Jun 2026
First submitted
6 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Luspatercept Injectable Product in people with Chemotherapy-inducing Anemia, run by Guangdong Second Provincial General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guopan Yu, PhD (+8615876559968, yugpp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of 50% increase in hemoglobin levels from baseline (time frame: Days 1-28 post chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07663864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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