NCT02244658

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 20, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

September 13, 2014

Last Update Submit

April 18, 2016

Conditions

Antineoplastic Adverse ReactionThrombocytopeniaAcute Myelocytic Leukemia

Keywords

chemotherapy-induced thrombocytopeniarecombinant human thrombopoietinacute myelocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

rhTPO

EXPERIMENTAL

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

Drug: rhTPO

control

NO INTERVENTION

no thrombopoietic agents

Interventions

rhTPODRUG

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

Also known as: TPIAO, S20050048/49 (SFDA, China)
rhTPO

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AML patients with PLT count \<30×10\^9/L during the previous cycle of chemotherapy to minimize the risk of clinically significant bleeding.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

ThrombocytopeniaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Ming Hou

CONTACT

houming@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 19, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

April 20, 2016

Record last verified: 2016-03

Locations

CN(1)