DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome, Ph^1^, Absent; B-cell Childhood Acute Lymphoblastic Leukemia

Intervention: Idarubicin(IDA) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Chinese Academy of Medical Sciences

Official(s) and/or principal investigator(s):
Xiaofan Zhu, MD, Principal Investigator, Affiliation: Chinese Academy of Medical Sciences

Overall contact:
Xiaofan Zhu, MD, Phone: +86-22-23909001, Email: xfzhu1981@126.com

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.

Clinical Details

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

Primary outcome: The event free survival of high risk ALL

Secondary outcome: The relapsed rate, death, overall survival

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.

Eligibility

Minimum age: 6 Months. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Xiaofan Zhu, MD, Phone: +86-22-23909001, Email: xfzhu1981@126.com

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses, Tianjin, Tianjin 300020, China; Recruiting
Xiaofan Zhu, MD, Phone: +86-22-23909001, Email: xfzhu1981@126.com
Xiaofan Zhu, MD, Principal Investigator
Additional Information

Starting date: October 2012
Last updated: November 20, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017