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New drug aims to fix anemia after stem cell transplants

NCT ID NCT07362095

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a drug called luspatercept (Reblozyl) to treat anemia in 46 people with acute leukemia who have had a stem cell transplant. The drug is given as a shot one and four weeks after transplant. The main goal is to see if it raises hemoglobin levels and reduces the need for blood transfusions. Researchers will also watch for side effects like infections or graft-versus-host disease.

What this could mean

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

Active substance
luspatercept (Reblozyl)
What this could lead to
If it works, this could offer a new way to treat anemia after stem cell transplant, reducing the need for blood transfusions and improving recovery.
What could go wrong
This is a very early, small study (46 people) with no comparison group. The drug may not improve hemoglobin levels, and risks like graft-versus-host disease or infections are possible.

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 46 people

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

Started

Oct 2025

Expected to finish

May 2028

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 70 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. Clinically diagnosed with acute leukemia. 2. Has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). 3. Expected to survive for more than 3 months from the date of signing the informed consent form. 4. Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, and has provided written informed consent. 5. Women of childbearing potential must have a negative serum pregnancy test within prior to enrollment. Female subjects who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential. Male and female subjects of reproductive potential must agree to use effective contraception throughout the study period. 6. Hemoglobin (Hb) level \< 80 g/L. Exclusion Criteria: 1\. Inadequate organ function, defined as: 1. Creatinine clearance \< 60 mL/min; 2. Left ventricular ejection fraction (LVEF) \< 55%; 3. Oxygen saturation (SpO₂) \< 92% on room air; 4. Total bilirubin \> 2 × the upper limit of normal (ULN); 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × ULN. 2. Poorly controlled hypertension, defined as repeated systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite adequate antihypertensive therapy, or a history of hypertensive crisis or hypertensive encephalopathy. 3\. History of other malignancies (except for acute leukemia), unless the subject has been disease-free for ≥5 years. However, subjects with the following history/concomitant conditions are eligible: 1. Basal or squamous cell carcinoma of the skin; 2. Carcinoma in situ of the cervix; 3. Carcinoma in situ of the breast; 4. Incidental histological finding of prostate cancer (T1a or T1b as defined by the TNM staging system); 5. Solid tumors considered by the investigator to have no other known active disease. 4\. Major surgery within 8 weeks prior to enrollment. The subject must have fully recovered from any prior surgery. 5\. History of cerebrovascular accident (including ischemic, embolic, and hemorrhagic), transient ischemic attack, deep vein thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to enrollment. Note: Prior superficial thrombophlebitis is not an exclusion criterion. 6\. Uncontrolled epilepsy, history of cerebral ischemia/hemorrhage, cerebellar disease, or other active central nervous system disorders. 7\. Cardiac disease within 6 months prior to enrollment, including: myocardial infarction, uncontrolled angina, acute decompensated heart failure, New York Heart Association (NYHA) Class III-IV heart failure, or uncontrolled arrhythmia (as determined by the investigator). 8\. Uncontrolled active systemic fungal, bacterial, or viral infection. 9. Evidence of human immunodeficiency virus (HIV) infection, active hepatitis B, and/or active hepatitis C. 10\. History of pure red cell aplasia (PRCA) and/or anti-erythropoietin antibody. 11\. Any condition or concomitant medication that may interfere with the interpretation of study data. 12\. Known hypersensitivity to luspatercept or any of its excipients.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Zhujiang Hospital

    RECRUITING

    Guangzhou, Guangdong, China

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