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

NCT ID: NCT01990807

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Childhood Acute Lymphoblastic Leukemia Philadelphia Chromosome, Ph^1^, Absent B-cell Childhood Acute Lymphoblastic Leukemia

Keywords

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high risk Philadelphia Chromosome absent Childhood acute lymphoblastic leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Idarubicin(IDA)

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

Group Type ACTIVE_COMPARATOR

Idarubicin(IDA)

Intervention Type DRUG

6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.

Interventions

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Idarubicin(IDA)

6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.

Intervention Type DRUG

Other Intervention Names

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darubicin, IDA, Demethoxydaunor Ubicin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Xiaofan Zhu

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

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Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofan Zhu, MD

Role: CONTACT

Phone: +86-22-23909001

Email: [email protected]

Facility Contacts

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Xiaofan Zhu, MD

Role: primary

Other Identifiers

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CCALL2012

Identifier Type: -

Identifier Source: org_study_id