Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia in Children: Remission Induction With All-transretinoic Acid (ATRA) and Arsenic Trioxide (As2O3). Consolidation With Daunorubicin(DNR)+Ara-c or DNR Alone.
1 Year
16 Years
Both
Leukemia
Trial Information
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia in Children: Remission Induction With All-transretinoic Acid (ATRA) and Arsenic Trioxide (As2O3). Consolidation With Daunorubicin(DNR)+Ara-c or DNR Alone.
Some studies suggest patients with high-risk disease should be treated with intensified
doses of anthracycline, or intermediate/ high-dose Ara-C or As2O3 as an early consolidation,
so as to decrease the risk of relapse.However, a higher cumulative dose of anthracycline may
lead to cardiac toxicity, especially for children. In addition, containing Ara-C will led to
more therapy-related toxicity. The benefit to add Ara-C to the schedules is questionable and
remains a matter of investigation in children.
Inclusion Criteria:
- Acute Promyelocytic Leukemia (APL)
Exclusion Criteria:
- > 16
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the impact of the addition of Ara-C to DNR courses of consolidation for patients on the disease-free survival
Outcome Time Frame:
two years
Safety Issue:
No
Principal Investigator
Xiaofan Zhu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Authority:
China: Ministry of Health
Study ID:
CCAPL2010
NCT ID:
NCT01191541
Start Date:
May 2010
Completion Date:
December 2018
Related Keywords:
- Leukemia
- ara-c
- As2O3
- pediatric
- acute
- Leukemia
- Leukemia, Promyelocytic, Acute
Name | Location |
|---|
