Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
Conditions
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
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: rhTPO
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 15 Years
Gender: Both
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;
Location
Qilu hospital, Shandong University
Jinan, Shandong, China
Status: Recruiting
Contact: Ming Hou - houming@medmail.com.cn
Start Date
September 2014
Completion Date
August 2015
Sponsors
Shandong University
Source
Shandong University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page