rhTPO + CsA vs CsA in the Treatment of LR-MDS With Thromb... | NCT07653581

Studies
rhTPO + CsA vs CsA in the Treatment of LR-MDS With Thrombocytopenia

NCT07653581

Sponsor

Peking Union Medical College Hospital

Status

Not yet recruiting

Last Update Posted

Jun 17, 2026Actual

Enrollment

78Estimated

Phase

Phase 3

Conditions

Lower-risk Myelodysplastic Syndromes

Interventions

rhTPO
Cyclosporine (CsA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Jun 7, 2026

First Submission Date that Met QC Criteria

Jun 11, 2026

First Posted Date

Jun 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rhTPO+CsA	Experimental	rhTPO 300U/kg/d, CsA 3-5mg/kg/d	Drug: rhTPO Drug: Cyclosporine (CsA)
CsA	Active Comparator	CsA 3-5mg/kg/d	Drug: Cyclosporine (CsA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhTPO	Drug	rhTPO 300U/kg/d, subcutaneous injection, once a month for 14 consecutive days	rhTPO+CsA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HI-P	hematological response - platelet	1-month, 2-month, 3-month, 6-month
ORR	ORR=CRR+PRR+HI	1-month, 2-month, 3-month, 6-month

Secondary Outcomes

Measure	Description	Time Frame
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	3-month, 6-month
Platelet transfusion independence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

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;
Previously used IL-11, rhTPO or TPO-RA;
Pregnant or lactating women;
Participated in other clinical trials within 3 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Bing Han, Doctor	Contact	+86 13601059938		hanbing_li@sina.com.cn

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016572	Cyclosporine

Ancestor Terms

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

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Browse Branches

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