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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDA-Etoposide Intensified Conditioning | Experimental |
| |
| Non-IDA Conditioning | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDA | Drug | Idarubicin: 15mg/m2/d: -8->-6d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Transplantation-Related Mortality | 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongsheng Zhou, PhD MD | Contact | 86-20-62787883 | hanson2008@gmail.com | |
| Qifa Liu, MD | Contact | 86-20-61641612 | liuqifa628@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu, MD | Department of Hematologym, Nanfang Hospital, Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Union Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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| Label | URL |
|---|---|
| Website of Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015255 | Idarubicin |
| D014916 | Whole-Body Irradiation |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| TBI | Radiation | TBI: 4.5 Gy/d, -5d, -4d |
|
|
| CTX | Drug | CY:60mg/kg/d, -3d, -2d |
|
|
| VP-16 | Drug | VP-16: 15mg/kg, -2d, -1d |
|
|
| Guangzhou General Hospital of Guangzhou Military Command | Recruiting | Guangzhou | Guangdong | 510010 | China |
|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | 510030 | China |
|
| Guangdong No.2 Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510317 | China |
|
| Department of Hematology, Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
|
| Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
|
| Department of Hematology, 1st Guangzhou People Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege | Recruiting | Guangzhou | Guangdong | China |
|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| Zhongshan People Hospital,Guangdong | Recruiting | Zhongshan | Guangdong | 528403 | China |
|
| Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
|
| Department of Hematology, Union Hospital, Huazhong Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
|
| Department of Hematology, Tongji Hospital, Huazhong Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |