Back to results

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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Idarubicin(IDA)

About this trial

This is an interventional treatment trial for Childhood Acute Lymphoblastic Leukemia focused on measuring high risk, Philadelphia Chromosome absent, Childhood acute lymphoblastic leukemia

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Idarubicin(IDA)

Arm Description

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

Outcomes

Primary Outcome Measures

The event free survival of high risk ALL

Secondary Outcome Measures

The relapsed rate, death, overall survival

Full Information

NCT ID

NCT01990807

First Posted

November 16, 2013

Last Updated

November 20, 2013

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01990807

Brief Title

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

Official Title

Philadelphia -Negative High-risk Children Acute Lymphoblastic Leukemia(ALL) Treatment:Induction Therapy:Vincristine(V),Idarubicin(I),L-asparaginase(L),Dexamethasone(D);Consolidation:V+Daunorubicin(D)+L+D, Methotrexate,Cytarabine

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

The prognosis of childhood acute lymphoblastic leukemia(ALL) has been increased. Tyrosine Kinase Inhibitor(TKI) has improved Philadelphia chromosome positive (Ph+)ALL treatment outcome. The prognosis of high-risk childhood ALL except for Philadelphia chromosome positive (Ph+)ALL is very bad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

high risk, Philadelphia Chromosome absent, Childhood acute lymphoblastic leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Idarubicin(IDA)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Idarubicin(IDA)

Other Intervention Name(s)

darubicin, IDA, Demethoxydaunor Ubicin

Intervention Description

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

Primary Outcome Measure Information:

Title

The event free survival of high risk ALL

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The relapsed rate, death, overall survival

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

infection rate

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children with high-risk ALL Children lower than 18years old Exclusion Criteria: Bcr/Abl(+) Children with middle-risk or standard-risk ALL

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaofan Zhu, MD

Phone

+86-22-23909001

xfzhu1981@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaofan Zhu, MD

Organizational Affiliation

Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaofan Zhu, MD

Phone

+86-22-23909001

xfzhu1981@126.com

First Name & Middle Initial & Last Name & Degree

Xiaofan Zhu, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs