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Not yet recruiting NCT07653581

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

Phase III Interventional Lower-risk Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rhTPO, Cyclosporine (CsA).
Who it may be relevant to
Registry conditions: Lower-risk Myelodysplastic Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

rhTPO + CsA Versus CsA Alone in the Treatment of Lower-risk MDS With Thrombocytopenia: a Single-center Randomized Controlled Trial

Overview

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.

Interventions

  • Drug rhTPO
    rhTPO 300U/kg/d, subcutaneous injection, once a month for 14 consecutive days
  • Drug Cyclosporine (CsA)
    CsA 3-5mg/kg/d

Primary outcome measures

  • HI-P [Time frame: 1-month, 2-month, 3-month, 6-month]
  • ORR [Time frame: 1-month, 2-month, 3-month, 6-month]
Secondary outcome measures (7)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07653581 · K10660

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗