Status:
UNKNOWN
A Randomized Trial of rhTPO Versus Placebo for Low/Intermediate-1 Risk MDS With Thrombocytopenia
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Low/Intermediate Risk-1 MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Myelodysplastic syndrome (MDS) is a kind of clonal myeloid tumor. The major manifestation is decrease of tri-lineages of blood due to ineffective and abnormal hematopoiesis, some of which can progress...
Eligibility Criteria
Inclusion
- Confirmed MDS, IPSS low / intermediate risk-1
- In the 4 weeks before inclusion, the average value of platelets was ≤ 30 × 10e9 / L, or \< 50 × 10e9 / L with bleeding events
- Patients with EPO due to anemia and G-CSF due to severe neutropenia can be included, and the dosage will not change during trial
- Baseline liver and kidney function: ALT / ASL within 3 times normal upper limit, TBIL within 2 times normal upper limit, and creatinine within 2 times normal upper limit
- ECOG 0-2 points
- Able to sign informed consent
Exclusion
- Pregnant or lactating
- IPSS intermediate risk-2 / high risk MDS
- More than 5% of myeloblasts in bone marrow
- Myelofibrosis
- Previous transplantation or ATG treatment within 6 months
- Previous use of IL-11, TPO or other TPO receptor agonists
- Active infection or tumor
- Thromboembolic or hemorrhagic disease
- Serious heart disease, including unstable angina, congestive heart failure, arrhythmia, 1-year history of myocardial infarction
- Intracranial hemorrhage within 4 weeks
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04324060
Start Date
March 1 2020
End Date
December 1 2022
Last Update
March 27 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking union medical college hospital
Beijing, China