An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia
16 Years
65 Years
Both
Acute Lymphoblastic Leukemia
Trial Information
An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia
It's well-known that the long-term outcome of adult acute lymphoblastic leukemia (ALL) lags
far behind that of pediatric ALL,associated 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 Methotrexate/L-asparaginase during consolidation
therapy,furthermore,risk/MRD-adapted allo-HSCT for high-risk and refractory/relapsed ALL.In
pre-pediatric-inspired protocol era, allo-HSCT still represents the major role for improving
the outcome of adult ALL, especially for high-risk and refractory/relapsed ALL. It's
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
resistance,reduce 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 TBI/CY2 conditioning regimen(data not yet
published). But at the same time, FA-TBI/CY2-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.
Inclusion Criteria:
1. Age: 16 years to 65 years;
2. Diagnosis of acute lymphoblastic leukemia;
3. Patient receives allo-HSCT;
4. The informed consent form has been signed;
Exclusion Criteria:
1. Patient with severe cardiac dysfunction with less than 50% EF;
2. Patient with severe lung dysfunction;
3. Patient with more than 3 times ULN of serum ALT or AST levels, or with more than 2
times ULN of serum TBIL level, or less than 40% of normal prothrombin time activity
(PTA); or with more than 2 times the ULN of serum Cr;
4. Patient with severe active infection;
5. Patient with allergy history about suspected drug in conditioning regimen;
6. Patient with other conditions considered unsuitable for the study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-Free Survival
Outcome Time Frame:
3 year
Safety Issue:
No
Principal Investigator
Qifa Liu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Hematologym, Nanfang Hospital, Southern Medical University, China
Authority:
China: Food and Drug Administration
Study ID:
HIE-ALL-2013
NCT ID:
NCT01873807
Start Date:
May 2013
Completion Date:
June 2015
Related Keywords:
- Acute Lymphoblastic Leukemia
- Idarubicin
- Etoposide
- HSCT
- Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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