Effect of rhIL-11 in Patients With Thrombocytopenia for C... | NCT02314273

Studies
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL

NCT02314273

Sponsor

Shanghai Children's Medical Center

Status

Completed

Last Update Posted

Dec 11, 2014Estimated

Enrollment

120Actual

Phase

Phase 4

Conditions

Pancytopenia Due to Chemotherapy

Interventions

rhIL-11

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 25, 2014

First Submission Date that Met QC Criteria

Dec 8, 2014

First Posted Date

Dec 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2014

Last Update Posted Date

Dec 11, 2014Estimated

Name	Class
Xiamen Amoytop Biotech Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.

Detailed Description

Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rhIL-11 group	Experimental	patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL	Drug: rhIL-11
control group	No Intervention	control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhIL-11	Drug	patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL	rhIL-11 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
platelet infusion	frequency of platelet infusion	14 days

Secondary Outcomes

Measure	Description	Time Frame
hemorrhagic tendency	conditions of bleeding	14 days
infection	incident of infection during 14d after chemotherapy	14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

new diagnosis of ALL
TBIL≤34umol/L，Cr≤120umol/L，a normal EF
age <18 years

Exclusion Criteria:

patients with uncontrolled infection
patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tang Jingyan, M.D.	Shanghai Children's Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Children's Hospital		Beijing	Beijing Municipality		China
Nanjing Children's Hospital

Intervention Browse Module

MeSH Terms

ID	Term
C105308	oprelvekin
D017370	Interleukin-11

Ancestor Terms

ID	Term
D007378	Interleukins
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided