Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01873807
Status:
UNKNOWN
Last Update Posted:
2015-10-09
First Post:
2013-06-06
Brief Title:
HD-IdarubicinEtoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
An Open-labelMulti-centerProspective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
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:
HITA
Brief Summary:
Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistancereduce tumor burden and most importantly spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease Our previous trial of HDE-ALL-2011 NCT01457040 have confirmed the role of intensified conditioning allo-HSCT in adult ALL resulting in significantly improved OS and EFS in comparison with previous standard TBICY2 conditioning regimendata not yet published But at the same time FA-TBICY2-VP16 conditioning regimen was associated with high transplantation-related mortality TRM which might be attributed to excessive suppression on both bone marrow and immune TT-ALL-HIE-2013 substituting FA with idarubicin is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM
Detailed Description:
Its well-known that the long-term outcome of adult acute lymphoblastic leukemia ALL lags far behind that of pediatric ALLassociated with different molecular cytogenetics make-up and treatment strategies In search of an optimal regimen for pediatric ALL comprehensive series of clinical trials of intensive chemotherapies have been conducted and lead to 80-90 long-term survival At the same time pediatric-inspired chemotherapy protocol aslo yielded a charming result of 50-60 3-year EFS in adolescent and young adult In comparison with the leading role of intensive chemotherapy in pediatric ALL allogeneic hematopoietic stem cell transplantation allo-HSCT plays an important role in treatment strategy of adult ALL According to the state-of-art understanding of ALL total therapy of ALL should consist of molecular-cytogenetics classification at diagnosis minimal residual disease MRD monitoring and redefining risk classification during treatment pediatric-inspired chemotherapy with high-dose MethotrexateL-asparaginase during consolidation therapyfurthermoreriskMRD-adapted allo-HSCT for high-risk and refractoryrelapsed ALLIn pre-pediatric-inspired protocol era allo-HSCT still represents the major role for improving the outcome of adult ALL especially for high-risk and refractoryrelapsed ALL Its established that graft-versus-leukemia GVL effect was weak in ALL and patient shows poor response for donor-lymphocyte infusion DLI Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistancereduce tumor burden and most importantly spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease Our previous trial of HDE-ALL-2011 NCT01457040 have confirmed the role of intensified conditioning allo-HSCT in adult ALL resulting in significantly improved OS and EFS in comparison with previous standard TBICY2 conditioning regimendata not yet published But at the same time FA-TBICY2-VP16 conditioning regimen was associated with high transplantation-related mortality TRM which might be attributed to excessive suppression on both bone marrow and immune TT-ALL-HIE-2013 substituting FA with idarubicin is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM
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