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Trial record 1 of 11 for:    "Adult Acute Lymphocytic Leukemia" | "Idarubicin"
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HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL (HITA)

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ClinicalTrials.gov Identifier: NCT01873807
Recruitment Status : Unknown
Verified October 2015 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : June 10, 2013
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: IDA Radiation: TBI Drug: CTX Drug: VP-16 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: IDA-Etoposide Intensified Conditioning Drug: IDA
Idarubicin: 15mg/m2/d: -8->-6d
Other Name: Idarubicin

Radiation: TBI
TBI: 4.5 Gy/d, -5d, -4d
Other Name: Total Body Irradiation

Drug: CTX
CY:60mg/kg/d, -3d, -2d
Other Name: Cyclophosphamide

Drug: VP-16
VP-16: 15mg/kg, -2d, -1d
Other Name: Etoposide

Active Comparator: Non-IDA Conditioning Radiation: TBI
TBI: 4.5 Gy/d, -5d, -4d
Other Name: Total Body Irradiation

Drug: CTX
CY:60mg/kg/d, -3d, -2d
Other Name: Cyclophosphamide

Drug: VP-16
VP-16: 15mg/kg, -2d, -1d
Other Name: Etoposide




Primary Outcome Measures :
  1. Event-Free Survival [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. Transplantation-Related Mortality [ Time Frame: 3 year ]


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873807


Contacts
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Contact: Hongsheng Zhou, PhD MD 86-20-62787883 hanson2008@gmail.com
Contact: Qifa Liu, MD 86-20-61641612 liuqifa628@163.com

Locations
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China, Fujian
Department of Hematology, Union Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China
Contact: Jianda Hu, MD         
Principal Investigator: Jianda Hu, MD         
China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Yang Xiao, MD       jdxiao111@163.com   
Principal Investigator: Yang Xiao, MD         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510030
Contact: Suijin Wu, MD       songwu55555@163.com   
Principal Investigator: Suijin Wu, MD         
Guangdong No.2 Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510317
Contact: Qing Zhang, MD       zhqing@vip.163.com   
Principal Investigator: Qing Zhang, MD         
Department of Hematology, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Hongsheng Zhou, MD PhD    86-20-62787883    hanson2008@gmail.com   
Contact: Qifa Liu, MD    86-20-61641612    liuqifa628@163.com   
Sub-Investigator: Hongsheng Zhou, MD PhD         
Third Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Dongjun Lin, MD       lindongjun0168@163.com   
Principal Investigator: Dongjun Lin, MD         
Department of Hematology, 1st Guangzhou People Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Shunqing Wang, MD         
Principal Investigator: Shunqing Wang, MD         
Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege Recruiting
Guangzhou, Guangdong, China
Contact: Huo Tan, MD PhD         
Principal Investigator: Huo Tan, MD PhD         
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Yuhua Li, MD PhD       li_yuhua@yahoo.com   
Principal Investigator: Yuhua Li, MD PhD         
Zhongshan People Hospital,Guangdong Recruiting
Zhongshan, Guangdong, China, 528403
Contact: Xiaojun Xu, MD       doctorxu@163.com   
Principal Investigator: Xiaojun Xu, MD         
China, Guangxi
Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Yongrong Lai, MD         
Principal Investigator: Yongrong Lai, MD         
China, Hubei
Department of Hematology, Union Hospital, Huazhong Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Yu Hu, MD PhD         
Principal Investigator: Yu Hu, MD PhD         
Department of Hematology, Tongji Hospital, Huazhong Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Jianfeng Zhou, MD PhD       jfzhou@tjh.tjmu.edu.cn   
Principal Investigator: Jianfeng Zhou, MD PhD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Qifa Liu, MD Department of Hematologym, Nanfang Hospital, Southern Medical University, China

Additional Information:
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01873807     History of Changes
Other Study ID Numbers: HIE-ALL-2013
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Keywords provided by Nanfang Hospital of Southern Medical University:
Idarubicin
Etoposide
HSCT
Acute Lymphoblastic Leukemia
Additional relevant MeSH terms:
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Idarubicin
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic