Ignite Creation Date:
2024-05-06 @ 3:07 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02200978
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2014-02-08
Brief Title:
A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
Sponsor:
South China Childrens Leukemia Group
Organization:
South China Childrens Leukemia Group
Study Overview
Official Title:
A Multicenter and Randomized Prospective Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Outcome of acute promyelocytic leukemia APL has greatly improved since the introduction of all-trans-retinoic acid ATRA Treatment with ATRA and anthracycline-based chemotherapy ATRA chemotherapy decreases relapses of the disease as well as early hemorrhagic deaths Nowadays patients with APL have an event-free survival EFS of up to 80 However there remains a subset of the patients in whom the disease relapses Recently a randomized prospective study showed that the addition of ATO to ATRA chemotherapy treatment protocol had a significantly higher EFS in patients with APL than those treated with ATRA chemotherapy protocol The patients treated with ATO ATRA chemotherapy had a five years EFS of 892 Moreover a recent study showed that Indigo naturalis formula RIF a traditional Chinese medicine with tetraarsenic tetrasulfide As4S4 indirubin and tanshinone IIA as major active ingredients yielded synergy in the treatment of a murine APL model in vivo and in the induction of APL cell differentiation in vitro It is about 20 years since RIF was used to treat ALP in China Clinical studies showed that this agent was effective against APL Compared to ATO RIF is relatively inexpensive and can be taken orally resulting in reducing the number of hospital days and the treatment cost However there is no report comparing treatment outcomes of ATO ATRA chemotherapy and RIF ATRA chemotherapy protocols in children with APL so far For this purpose therefore investigators are going to conduct a multicenter and randomized prospective study in children with APL
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of ATORIF ATRA less intensive chemotherapy protocol in children with acute promyelocytic leukemia APL
Compare the safetyefficacy and treatment cost of RIF ATRA less intensive chemotherapy with ATO ATRA less intensive chemotherapy protocol in children with APL Determine if ATO can be substituted by RIF
OUTLINE This is a multicenter and randomized prospective study
PROJECTED ACCRUAL A total of 162 patients will be accrued for this study
Determine the safety and efficacy of ATORIF ATRA less intensive chemotherapy protocol in children with acute promyelocytic leukemia APL
Compare the safetyefficacy and treatment cost of RIF ATRA less intensive chemotherapy with ATO ATRA less intensive chemotherapy protocol in children with APL Determine if ATO can be substituted by RIF
OUTLINE This is a multicenter and randomized prospective study
PROJECTED ACCRUAL A total of 162 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None