Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia

Shandong University

Status and phase

Unknown

Phase 3

Conditions

Antineoplastic Adverse Reaction

Thrombocytopenia

Acute Myelocytic Leukemia

Treatments

Drug: rhTPO

Study type

Interventional

Funder types

Other

Identifiers

NCT02244658

RhTPO-AML thrombocytopenia

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

15 to 75 years old

Volunteers

No Healthy Volunteers

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;