Myelodysplastic SyndromesNCT07073690
Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in China
An observational study of Myelodysplastic Syndromes, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Luspatercept
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2025to 12 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise of individuals ≥18 years of age diagnosed with Lower-Risk Myelodysplastic Syndromes (LR-MDS) were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China
Who may be able to join
- Participants ≥ 18 years of age.
- Documented diagnosis of no del(5q) MDS that meets lower-risk Myelodysplastic Syndromes (MDS) classification. (Diagnosis criteria and risk classification criteria are based on clinical practice)
- Patients who were erythropoiesis-stimulating agent (ESA)-naïve have received luspatercept monotherapy at least 2 cycles regardless of RS status.
- Historical documentation of anemia before luspatercept treatment.
Who cannot join
- Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis.
- Received stem cell transplant prior to luspatercept treatment initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Treatment Patterns and Outcomes of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes (LR-MDS) in China ('REACH' Study)
The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Luspatercept
- Keywords
- Lower Risk Myelodysplastic Syndromes
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving luspatercept treatment | Not described Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant red blood cell transfusion independence
Measured: Up to 12-weeks
Participants mean hemoglobin (Hb) increase ≥1.5 g/dL
Measured: Up to 12-weeks
Secondary outcomes (3)
Participant transfusion independence and increase in hemoglobin (Hb)
Measured: Up to 48 weeks
Duration of luspatercept monotherapy treatment
Measured: Up to 48 weeks
Health Care Resource Utilization (HCRU)
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start18 Apr 2025
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073690
- Sponsor's protocol ID
- CA056-1166
- Status last verified
- May 2026
- First submitted
- 10 Jul 2025
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Outcomes of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes (LR-MDS) in China ('REACH' Study)
- ClinicalTrials.gov ID
- NCT07073690
- Acronym / sponsor ID
- CA056-1166
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Lower Risk Myelodysplastic Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving luspatercept treatment | – | Drug: Luspatercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise of individuals ≥18 years of age diagnosed with Lower-Risk Myelodysplastic Syndromes (LR-MDS) were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China
Key inclusion criteria (4 listed)
- Participants ≥ 18 years of age.
- Documented diagnosis of no del(5q) MDS that meets lower-risk Myelodysplastic Syndromes (MDS) classification. (Diagnosis criteria and risk classification criteria are based on clinical practice)
- Patients who were erythropoiesis-stimulating agent (ESA)-naïve have received luspatercept monotherapy at least 2 cycles regardless of RS status.
- Historical documentation of anemia before luspatercept treatment.
Key exclusion criteria (2 listed)
- Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis.
- Received stem cell transplant prior to luspatercept treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuspaterceptAccording to the product label | Drug | Participants receiving luspatercept treatment |
Primary outcome
Participant red blood cell transfusion independence
Time frame: Up to 12-weeks
Participants mean hemoglobin (Hb) increase ≥1.5 g/dL
Time frame: Up to 12-weeks
3 secondary outcomes
Participant transfusion independence and increase in hemoglobin (Hb)
Time frame: Up to 48 weeks
Duration of luspatercept monotherapy treatment
Time frame: Up to 48 weeks
Health Care Resource Utilization (HCRU)
Time frame: Up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Bristol-Myers Squibb 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 19 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant red blood cell transfusion independence (time frame: Up to 12-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.