Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia

Phase 4

• Conditions: Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome, Ph^1^, Absent; B-cell Childhood Acute Lymphoblastic Leukemia
• Interventions: Drug: Idarubicin(IDA)

• Registration Number: NCT01990807
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly in recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in some high risk groups, The prognosis of patients is still very bad and the relapse rate is high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.

Detailed Description

1. The prognosis of childhood acute lymphoblastic leukemia(ALL) has been increased.

2. Tyrosine Kinase Inhibitor(TKI) has improved Philadelphia chromosome positive (Ph+)ALL treatment outcome.

3. The prognosis of high-risk childhood ALL except for Philadelphia chromosome positive (Ph+)ALL is very bad.

Study Timeline

• Study Start: 2012-10
• Status Verified: 2013-11
• Study First Submitted: 2013-11-16
• Study First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Children with high-risk ALL Children lower than 18years old

Exclusion Criteria

Bcr/Abl(+) Children with middle-risk or standard-risk ALL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Idarubicin(IDA)	Idarubicin(IDA)	philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times

Primary Outcome Measures

Name	Time	Method
The event free survival of high risk ALL	2 years

Secondary Outcome Measures

Name	Time	Method
The relapsed rate, death, overall survival	2 years

Trial Locations

Locations (1)

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses; 🇨🇳 Tianjin, Tianjin, China