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Trial Title:
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
NCT ID:
NCT02244658
Condition:
Antineoplastic Adverse Reaction
Thrombocytopenia
Acute Myelocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Thrombocytopenia
Conditions: Keywords:
chemotherapy-induced thrombocytopenia
recombinant human thrombopoietin
acute myelocytic leukemia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
rhTPO
Description:
rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days
Arm group label:
rhTPO
Other name:
TPIAO
Other name:
S20050048/49 (SFDA, China)
Summary:
Chemotherapy-related myelosuppression usually occurs in AML patients, which induces
severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial
aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced
thrombocytopenia in acute myelocytic leukemia.
Detailed description:
The investigators are undertaking a parallel group, multicentre, randomized controlled
trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in
China. AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy
are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for
7~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor.
Platelet count, bleeding and other symptoms were evaluated before and after treatment.
Adverse events are also recorded throughout the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy to
minimize the risk of clinically significant bleeding.
Exclusion Criteria:
- allergic history to biological agents; history of thrombotic or hemorrhagic
diseases; M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease;
diabetes; liver and kidney function impairment;
Gender:
All
Minimum age:
15 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu hospital, Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Hou
Email:
houming@medmail.com.cn
Investigator:
Last name:
Ming Hou
Email:
Principal Investigator
Start date:
September 2014
Completion date:
August 2017
Lead sponsor:
Agency:
Shandong University
Agency class:
Other
Source:
Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02244658
