Lower-risk Myelodysplastic SyndromesPhase 3NCT07653581
rhTPO + CsA vs CsA in the Treatment of LR-MDS With Thrombocytopenia
A Phase 3 study testing rhTPO and Cyclosporine (CsA) in people with Lower-risk Myelodysplastic Syndromes, run by Peking Union Medical College Hospital.
Trial summary
This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower-risk Myelodysplastic Syndromes
- What is being tested?
- rhTPO and Cyclosporine (CsA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years old;
- Confirmed diagnosis of lower-risk MDS;
- Platelet ≤ 30×109/L, or < 50×109/L and accompanied by bleeding events;
- Baseline liver and kidney functions <2 ULN;
- Signed the informed consent form;
- ECOG 0-2;
Who cannot join
- History of leukemia or stem cell transplantation, treatment-related MDS or malignant tumors;
- With splenomegaly or myelofibrosis;
- Infections or bleeding that cannot be controlled by standard treatment;
- Any concurrent malignant tumors within the past 5 years, or basal cell carcinoma of the skin at the local site;
- History of thromboembolic events, heart attack or stroke and current use of anticoagulants;
- Previously received cyclosporine (CsA) or ATG within 6 months;
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- Previously used IL-11, rhTPO or TPO-RA;
- Pregnant or lactating women;
- Participated in other clinical trials within 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: rhTPO + CsA Versus CsA Alone in the Treatment of Lower-risk MDS With Thrombocytopenia: a Single-center Randomized Controlled Trial
This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia.
- Conditions
- Lower-risk Myelodysplastic Syndromes
- Being tested
- rhTPO, Cyclosporine (CsA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
rhTPO 300U/kg/d, subcutaneous injection, once a month for 14 consecutive days
Cyclosporine (CsA)Drug
CsA 3-5mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| rhTPO+CsA | Experimental | rhTPO 300U/kg/d, CsA 3-5mg/kg/d Receives: Drug: rhTPO; Drug: Cyclosporine (CsA) |
| CsA | Active comparator | CsA 3-5mg/kg/d Receives: Drug: Cyclosporine (CsA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HI-P
hematological response - platelet
Measured: 1-month, 2-month, 3-month, 6-month
ORR
ORR=CRR+PRR+HI
Measured: 1-month, 2-month, 3-month, 6-month
Secondary outcomes (7)
Number of bleeding incidents and severity assessed by the World Health Organization Bleeding Scale
minimum value = 0, maximum value = 4; higher scores indicate worse outcome
Measured: 3-month, 6-month
Platelet transfusion independence
according to the number and interval of platelet transfusions
Measured: 3-month, 6-month
Time to CR/OR
Time from baseline to first response
Measured: through study period, an average of 6 months
Duration of HI-P
Time to patients achieving HI-P to losing response
Measured: through study period, an average of 6-month
Quality of life score measured by the Short Form-36 Health Survey
minimum value = 0, maximum value = 100; higher scores indicate better quality of life
Measured: 3-month
Clonal evolution
The incidence of elevation of blast cells in bone marrow and peripheral blood within one year, and the incidence of progressing to higher-risk MDS or AML within one year
Measured: 12-month
OS
Overall survival (OS), defined as the time from randomization/treatment start to death from any cause.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower-risk Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Han, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653581
- Sponsor's protocol ID
- K10660
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rhTPO + CsA Versus CsA Alone in the Treatment of Lower-risk MDS With Thrombocytopenia: a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07653581
- Acronym / sponsor ID
- K10660
- Conditions
- Lower-risk Myelodysplastic Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Jun 2026 (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.
This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTPO+CsA | Experimental | Drug: rhTPO, Drug: Cyclosporine (CsA)rhTPO 300U/kg/d, CsA 3-5mg/kg/d |
| CsA | Active comparator | Drug: Cyclosporine (CsA)CsA 3-5mg/kg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old;
- Confirmed diagnosis of lower-risk MDS;
- Platelet ≤ 30×109/L, or < 50×109/L and accompanied by bleeding events;
- Baseline liver and kidney functions <2 ULN;
- Signed the informed consent form;
Key exclusion criteria (9 listed)
- History of leukemia or stem cell transplantation, treatment-related MDS or malignant tumors;
- With splenomegaly or myelofibrosis;
- Infections or bleeding that cannot be controlled by standard treatment;
- Any concurrent malignant tumors within the past 5 years, or basal cell carcinoma of the skin at the local site;
- History of thromboembolic events, heart attack or stroke and current use of anticoagulants;
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 |
|---|---|---|
| rhTPOrhTPO 300U/kg/d, subcutaneous injection, once a month for 14 consecutive days | Drug | rhTPO+CsA |
| Cyclosporine (CsA)CsA 3-5mg/kg/d | Drug | CsA, rhTPO+CsA |
Primary outcome
HI-P
Time frame: 1-month, 2-month, 3-month, 6-month
hematological response - platelet
ORR
Time frame: 1-month, 2-month, 3-month, 6-month
ORR=CRR+PRR+HI
7 secondary outcomes
Number of bleeding incidents and severity assessed by the World Health Organization Bleeding Scale
Time frame: 3-month, 6-month
Platelet transfusion independence
Time frame: 3-month, 6-month
Time to CR/OR
Time frame: through study period, an average of 6 months
Duration of HI-P
Time frame: through study period, an average of 6-month
Quality of life score measured by the Short Form-36 Health Survey
Time frame: 3-month
Clonal evolution
Time frame: 12-month
OS
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhTPO and Cyclosporine (CsA) in people with Lower-risk Myelodysplastic Syndromes, run by Peking Union Medical College Hospital.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bing Han, Doctor (+86 13601059938, hanbing_li@sina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HI-P (time frame: 1-month, 2-month, 3-month, 6-month). 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 17 Jun 2026.