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

ConditionLower-risk Myelodysplastic Syndromes
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • rhTPO

    Drug

    rhTPO 300U/kg/d, subcutaneous injection, once a month for 14 consecutive days

  • Cyclosporine (CsA)

    Drug

    CsA 3-5mg/kg/d

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: rhTPO+CsAExperimental treatment 2 interventions
Group B: CsAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

HI-P

hematological response - platelet

Time frame
1-month, 2-month, 3-month, 6-month
2

ORR

ORR=CRR+PRR+HI

Time frame
1-month, 2-month, 3-month, 6-month

Secondary outcomes

1

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

Time frame
3-month, 6-month
2

Platelet transfusion independence

according to the number and interval of platelet transfusions

Time frame
3-month, 6-month
3

Time to CR/OR

Time from baseline to first response

Time frame
through study period, an average of 6 months
4

Duration of HI-P

Time to patients achieving HI-P to losing response

Time frame
through study period, an average of 6-month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: