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Could a drug help AML patients fight Chemo-Related anemia?

NCT ID NCT07663864

Disease control Sponsor: Guangdong Second Provincial General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates whether luspatercept can treat anemia caused by chemotherapy in adults with low-risk acute myeloid leukemia (AML). Participants receive luspatercept injections after chemotherapy, and researchers monitor hemoglobin levels and safety. The study aims to find the best timing for the drug and assess its effectiveness in reducing severe anemia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
luspatercept
What this could lead to
If it works, this could offer a new way to manage chemotherapy-induced anemia in AML patients, reducing the need for blood transfusions.
What could go wrong
This is an early-phase, single-arm study with only 40 participants, so results may not be generalizable. The drug may not effectively raise hemoglobin or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy-inducing anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Hematology, Guangdong Second Provincial General Hospital

    RECRUITING

    Guangzhou, Guangdong, China