NCT02314273

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

December 11, 2014

Status Verified

November 1, 2014

Enrollment Period

2.6 years

First QC Date

July 25, 2014

Last Update Submit

December 8, 2014

Conditions

Pancytopenia Due to Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • platelet infusion

    frequency of platelet infusion

    14 days

Secondary Outcomes (4)

  • hemorrhagic tendency

    14 days

  • infection

    14 days

  • remission rate

    14 days

  • platelet Count

    14 days

Study Arms (2)

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

rhIL-11DRUG

patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL

Also known as: Recombinant Human Interleukin-11
rhIL-11 group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Children's Hospital

Beijing, Beijing Municipality, China

Location

Nanjing Children's Hospital

Nanjing, Jiangsu, China

Location

Soochow University Affiliated Children's Hospital

Suzhou, Jiangsu, China

Location

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

oprelvekinInterleukin-11

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Tang Jingyan, M.D.

    Shanghai Children's Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

December 11, 2014

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 11, 2014

Record last verified: 2014-11

Locations

CN(5)