A Phase 3 interventional study of Azacitidine (AZA) and Luspatercept in Higher-risk Myelodysplastic Syndrome, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Peking Union Medical College Hospital · 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 9th largest by planned enrollment, is the only one that started in 2025, is one of 8 in phase 3, reaches primary completion later than 4 of the 12 other live ones, and was the 18th 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+
Institute of Hematology & Blood Diseases Hospital, China
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.
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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 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 86 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:
Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Peking Union Medical College Hospital has 6 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 randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.
The hypomethylating agents (HMA) azacitidine (AZA) and decitabine (DEC) have been shown to improve survival and delay disease progression in patients with high-risk MDS. They are recommended by the NCCN as first-line treatments for patients with high-risk MDS. Clinical trials have demonstrated an OR rate of approximately 40-50% with AZA in patients with high-risk MDS. Despite the efficacy of HMA therapy, the rate of transfusion independence remains low. Anemia remains the most prominent symptom in refractory patients, with very limited options for subsequent treatment. Prolonged anemia affects every organ function and seriously affects the prognosis of patients.
Luspatercept is currently approved for the treatment of patients with both erythropoiesis receptor agonist ( ESA) treatment failures in transfusion-dependent low-risk MDS-RS patients. In a randomized controlled phase III clinical trial, compared to a placebo group, luspatercept significantly improved transfusion dependence and improved hemoglobin and quality of life in refractory MDS-RS patients. A recent conference report suggested that there was no significant difference in efficacy between low-risk and high-risk patients treated with luspatercept and that the HI rate for high-risk patients treated with luspatercept monotherapy was approximately 50%.
Thus this study aimed to compare the efficacy of AZA+luspatercept and AZA monotherapy.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Azacitidine (AZA) · Drug: Luspatercept
Drug: Azacitidine (AZA)
Azacitidine 75mg/m/ day \*5 days, 28 days for 1 course
Luspatercept 1.0 mg/kg subcutaneously every 3 weeks, adjusted according to hemoglobin, up to 1.75mg/kg. If hemoglobin ≥120g/L, luspatercept can be discontinued.
overall response rate
Time frame: 3 months, 6 months
complete response rate
Time frame: 3 months, 6 months
rate of transfusion independence
Time frame: 3 months, 6 months
adverse event rate
Time frame: through study completion, an average of 1 year
relapse rate
Time frame: through study completion, an average of 1 year
progress-free survival
Time frame: through study completion, an average of 1 year
overall survival
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
Start is estimated for Apr 2025; primary completion for Jan 2026, 9 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 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Luspatercept
Peking Union Medical College Hospital →