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

Primary Purpose

Antineoplastic Adverse Reaction, Thrombocytopenia, Acute Myelocytic Leukemia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

rhTPO

About this trial

This is an interventional treatment trial for Antineoplastic Adverse Reaction focused on measuring chemotherapy-induced thrombocytopenia, recombinant human thrombopoietin, acute myelocytic leukemia

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Qilu hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

rhTPO

control

Arm Description

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

no thrombopoietic agents

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02244658

First Posted

September 13, 2014

Last Updated

April 18, 2016

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT02244658

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antineoplastic Adverse Reaction, Thrombocytopenia, Acute Myelocytic Leukemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rhTPO

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

no thrombopoietic agents

Intervention Type

Drug

Intervention Name(s)

rhTPO

Other Intervention Name(s)

TPIAO, S20050048/49 (SFDA, China)

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluation of platelet response

Description

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.

Time Frame

21 days since the first administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou

houming@medmail.com.cn

Facility Information:

Facility Name

Qilu hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Hou

houming@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Ming Hou

12. IPD Sharing Statement

Learn more about this trial

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

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