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

NCT01990807 — Phase 4, Unknown, 20 participants, Chinese Academy of Medical Sciences

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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

Registry	NCT01990807
Status	Unknown
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Chinese Academy of Medical Sciences (Other)
Conditions	Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome, Ph^1^, Absent, B-cell Childhood Acute Lymphoblastic Leukemia
Interventions	Idarubicin(IDA) (Drug)
Dates	start 2012-10-01, primary completion 2014-10-01 (estimated), completion 2014-10-01 (estimated), first posted 2013-11-21, last updated 2013-11-21
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Idarubicin(IDA)	Active comparator	Drug: Idarubicin(IDA)	philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times

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

+Outcome measures

Primary outcomes

The event free survival of high risk ALL [2 years]

Secondary outcomes

The relapsed rate, death, overall survival [2 years]

Other outcomes

infection rate [2 years]

+Eligibility

Sex: All, ages: 6 Months to 18 Years

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 (1)

Facility	City	Country	Status
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses	Tianjin, Tianjin Municipality	China	Recruiting

+Investigators

Xiaofan Zhu, MD, Principal investigator, Chinese Academy of Medical Sciences