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HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL

Information source: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: IDA-Etoposide Intensified Conditioning (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Nanfang Hospital of Southern Medical University

Official(s) and/or principal investigator(s):
Qifa Liu, MD, Principal Investigator, Affiliation: Department of Hematologym, Nanfang Hospital, Southern Medical University, China

Overall contact:
Hongsheng Zhou, PhD MD, Phone: 86-20-62787883, Email: hanson2008@gmail.com

Summary

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-Free Survival

Secondary outcome: Transplantation-Related Mortality

Detailed description: 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.

Eligibility

Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hongsheng Zhou, PhD MD, Phone: 86-20-62787883, Email: hanson2008@gmail.com

Department of Hematology, Union Hospital of Fujian Medical University, Fuzhou, Fujian, China; Recruiting
Jianda Hu, MD
Jianda Hu, MD, Principal Investigator

Department of Hematology, 1st Guangzhou People Hospital, Guangzhou, Guangdong, China; Recruiting
Shunqing Wang, MD
Shunqing Wang, MD, Principal Investigator

Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, China; Recruiting
Hongsheng Zhou, MD PhD, Phone: 86-20-62787883, Email: hanson2008@gmail.com
Qifa Liu, MD, Phone: 86-20-61641612, Email: liuqifa628@163.com
Hongsheng Zhou, MD PhD, Sub-Investigator

Guangdong General Hospital, Guangzhou, Guangdong 510030, China; Recruiting
Suijin Wu, MD, Email: songwu55555@163.com
Suijin Wu, MD, Principal Investigator

Guangdong No.2 Provincial People's Hospital, Guangzhou, Guangdong 510317, China; Recruiting
Qing Zhang, MD, Email: zhqing@vip.163.com
Qing Zhang, MD, Principal Investigator

Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, Guangdong 510010, China; Recruiting
Yang Xiao, MD, Email: jdxiao111@163.com
Yang Xiao, MD, Principal Investigator

Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege, Guangzhou, Guangdong, China; Recruiting
Huo Tan, MD PhD
Huo Tan, MD PhD, Principal Investigator

Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510630, China; Recruiting
Dongjun Lin, MD, Email: lindongjun0168@163.com
Dongjun Lin, MD, Principal Investigator

Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China; Recruiting
Yuhua Li, MD PhD, Email: li_yuhua@yahoo.com
Yuhua Li, MD PhD, Principal Investigator

Zhongshan People Hospital,Guangdong, Zhongshan, Guangdong 528403, China; Recruiting
Xiaojun Xu, MD, Email: doctorxu@163.com
Xiaojun Xu, MD, Principal Investigator

Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, China; Recruiting
Yongrong Lai, MD
Yongrong Lai, MD, Principal Investigator

Department of Hematology, Tongji Hospital, Huazhong Science and Technology, Wuhan, Hubei 430030, China; Recruiting
Jianfeng Zhou, MD PhD, Email: jfzhou@tjh.tjmu.edu.cn
Jianfeng Zhou, MD PhD, Principal Investigator

Department of Hematology, Union Hospital, Huazhong Science and Technology, Wuhan, Hubei 430022, China; Recruiting
Yu Hu, MD PhD
Yu Hu, MD PhD, Principal Investigator

Additional Information

Website of Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.

Starting date: May 2013
Last updated: June 7, 2013

Page last updated: August 23, 2015

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