Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT02267993
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2014-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients
Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Organization:
Study Overview
Official Title:
A Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Thrombopoietin in the Treatment of Thrombocytopenia After Chemotherapy in Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
Detailed Description:
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission following induction chemotherapy will be recruited and randomized into two groups, of 60 cases in each group. For one group, the treatment cycle is in the first chemotherapy cycle and the control cycle is in the second one. For another group, the treatment cycle is in the second chemotherapy cycle and the control cycle is in the first one.
Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once daily at a platelet count of \< 50×109/L, and rhTPO treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.
Each subject is required to be followed up for successive two chemotherapy cycles following inclusion in this study. During the follow-up period, routine blood test is performed once every other day, and platelet transfusion is recorded.
The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once daily at a platelet count of \< 50×109/L, and rhTPO treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.
Each subject is required to be followed up for successive two chemotherapy cycles following inclusion in this study. During the follow-up period, routine blood test is performed once every other day, and platelet transfusion is recorded.
The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: