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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02244658
• Other study ID #: RhTPO-AML thrombocytopenia
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2014
• Last updated: April 18, 2016
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: March 2016
• Source: Shandong University
• Contact: Ming Hou
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: People's Republic of China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelocytic Leukemia
• Antineoplastic Adverse Reaction
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• rhTPO
rhTPO 1.0 µg/kg·d subcutaneously for 7~14 consecutive days

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of platelet response	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.	21 days since the first administration	Yes