A Phase 3 interventional study of Luspatercept in Myelodysplastic Syndromes, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 3, Interventional, and Treatment
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Among 19 studies testing luspatercept in Myelodysplastic Syndromes — 7 open to participants now, 13 under way, 7 of them phase 3. luspatercept · Myelodysplastic Syndromes.
Among the 19 studies testing luspatercept in Myelodysplastic Syndromes, this one is the 10th largest by planned enrollment, is the only one that started in 2026, is one of 8 in phase 3, reaches primary completion later than 8 of the 12 other live ones, and was the 19th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →7 of the 19 studies testing luspatercept in Myelodysplastic Syndromes are open now, in 12 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States, Canada, Puerto Rico
Ages 18+
Associazione Qol-one · Sites in Italy
Ages 18+
University of Leipzig · Sites in Germany
Ages 18+
Celgene · Sites in United States, Australia, Belgium and 19 more countries
Ages 18+
Peking Union Medical College Hospital
Ages 18+
By country, each count listing its studies:
luspatercept: first FDA approval 2019 (REBLOZYL), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 10 · Phase 3 8 · Phase 4 1
First in 2013; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 75 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 75 across the 19 interventional studies. Of the 5 that completed or were terminated, 4 (80%) have results posted.
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9 of 19 have an industry lead sponsor. The 10 most frequent:
Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 412 studies on the registry; 291 are open to participants now.
Institute of Hematology & Blood Diseases Hospital, China has 5 studies filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
1 of the studies testing luspatercept in Myelodysplastic Syndromes that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07894861Phase 3Institute of Hematology & Blood Diseases Hospital, ChinaEfficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes | 2027-06-30 |
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Among the 19 studies testing luspatercept in Myelodysplastic Syndromes, from their registry updates:
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This study is a single-arm, prospective, multi-center, Phase IIIb clinical trial aimed at evaluating the efficacy and safety of the maximum labeled dose of luspatercept in individuals diagnosed with lower-risk myelodysplastic syndromes (MDS). The trial anticipates the enrollment of 75 participants with lower-risk MDS, all of whom will undergo treatment with luspatercept.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Luspatercept
The patients will undergo a maximum 4-week screening period and then enter the treatment phase, where they will receive subcutaneous injections of luspatercept at 1.75 mg/kg every 3 weeks. If adverse events occur during the treatment, the dosage will be reduced or administration postponed depending on their severity.
Proportion of patients achieving red blood cell transfusion independence (RBC-TI) for at least 8 weeks
RBC-TI is evaluated by hemoglobin levels and transfusion status
Time frame: 24 weeks
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 7 months later.
Of 45 phase 3 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 95. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Luspatercept
Institute of Hematology & Blood Diseases Hospital, China →