Trials / Unknown
UnknownNCT01990807
Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 6 Months – 18 Years
- Healthy volunteers
- Not accepted
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
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
- Childhood Acute Lymphoblastic Leukemia
- Philadelphia Chromosome, Ph^1^, Absent
- B-cell Childhood Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idarubicin(IDA) | 6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2013-11-21
- Last updated
- 2013-11-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01990807. Inclusion in this directory is not an endorsement.