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An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia

Phase 4
16 Years
65 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia

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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:


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:


Principal Investigator

Qifa Liu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematologym, Nanfang Hospital, Southern Medical University, China


China: Food and Drug Administration

Study ID:




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