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

Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02244658

Enrollment

Registered

2014-09-19

Start date

2014-09-30

Completion date

2017-08-31

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myelocytic Leukemia, Antineoplastic Adverse Reaction, Thrombocytopenia

Keywords

chemotherapy-induced thrombocytopenia, recombinant human thrombopoietin, acute myelocytic leukemia

Brief 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.

Interventions

DRUGrhTPO

rhTPO 1.0 μg/kg·d subcutaneously for 7\ 14 consecutive days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 75 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of platelet response	21 days since the first administration	days that PLT count rebound to 30×10\^9/L, 50×10\^9/L and 100×10\^9/L, respectively, from the minimal level after the very cycle of chemotherapy.

Countries

China

Contacts

Primary ContactMing Hou

houming@medmail.com.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026