Blood and Lymph Conditions

All Conditions

Thrombocytopenia

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

The study in a 2:1 randomization ratio (110 subjects to rhTPO).

The study in a 2:1 randomization ratio (55 subjects to control group).

rhTPO 300U/kg/d QD, subcutaneous injection applied for 5 days per cycle, total 3 cycles. If the patient's platelet count showed a trend of continuous decline and/or was accompanied by the risk of bleeding during the treatment or after the completion of 5 doses of rhTPO, the investigator judged that rhTPO should be continued for treatment, and rhTPO could be administered subcutaneously at 300U/kg/ day for a maximum of 14 doses per cycle. Discontinue when the absolute platelet count increases by ≥50×10\^9/L or when the platelet count rises to ≥250×10\^9/L.

rhTPO

Control

Jiwei Liu, MD

Fengqi Fang, MD

Chenghui Li

Shengyu Zhou

Lijie Zuo

Xiaodong Wang

Xuechun Lu

Jian Shi

Shundong Cang

Jufeng Wang

Gang Wu

Yongsheng Jiang

Lei Yang

Jiwei Liu

Fengqi Fang

Tao Sun

Guoqing Wang

Huilai Zhang

Yunlong Xia, MD,PhD

To assess the efficacy and safety of an optimised dosing regimen of rhTPO's prophylactic treatment of cancer treatment-induced thrombocytopenia(CTIT) and to explore the cardioprotective effect of rhTPO in cancer patients with high risk of treatment-induced cardiac injury.

This is an open-label prospective randomized multicenter study of rhTPO's prophylactic treatment of CTIT in patients receiving chemotherapy at high risk of cardiac injury. Adult cancer patients with high risk of cancer treatment-induced thrombocytopenia and cardiac injury were enrolled. Patients will be randomised into the rhTPO treatment group or non-rhTPO treatment group with a 2:1 ratio. The patients in rhTPO group will receive rhTPO 300U/kg/d subcutaneous injection for 5 days per cycle and total 3 cycles. The primary endpoint is to observe the improvement of platelet count by rhTPO during 3 cycles treatment period.

Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury

A Multicenter Randomized Controlled Study to Assess the Efficacy and Safety of rhTPO's Prophylactic Treatment of Cancer Treatment-induced Thrombocytopenia in Patients With High Risk of Treatment-induced Cardiac Injury

Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.

Efficacy was defined as treatment without salvage therapy to increase platelet counts.

Salvage treatment including platelet infusion, rhIL-11, etc.

LVEF will be assessed by echocardiography

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Anqing Municipal Hospital

Henan Cancer Hospital

Wuhan Union Hospital, China

Peking University Shougang Hospital

Chinese PLA General Hospital

Liaoning Tumor Hospital & Institute

Tianjin Medical University Cancer Institute and Hospital

Henan Provincial People's Hospital

Shanxi Provincial Cancer Hospital

Beijing Sanhuan Cancer Hospital

Hebei Medical University Fourth Hospital

Tongji Hospital

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Bethune Charitable Foundation

The First Affiliated Hospital of Dalian Medical University

Director

Spots Global Cancer Trial Database for cancer treatment induced thrombocytopenia