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

Childhood Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01990807
• Other study ID #: CCALL2012
• Status: Recruiting
• Phase: Phase 4
• First received: November 16, 2013
• Last updated: November 20, 2013
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2013
• Source: Chinese Academy of Medical Sciences
• Contact: Xiaofan Zhu, MD
• Phone: +86-22-23909001
• Email: xfzhu1981[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Childhood Acute Lymphoblastic Leukemia
• Childhood Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Philadelphia Chromosome, Ph^1^, Absent
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	infection rate		2 years	Yes
Primary	The event free survival of high risk ALL		2 years	Yes
Secondary	The relapsed rate, death, overall survival		2 years	Yes