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

Phase 3

• Conditions: Acute Myelocytic Leukemia; Thrombocytopenia; Antineoplastic Adverse Reaction
• Interventions: Drug: rhTPO

• Registration Number: NCT02244658
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-13
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Status Verified: 2016-03
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhTPO	rhTPO	rhTPO 1.0 μg/kg·d subcutaneously for 7\~14 consecutive days

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China