HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL
HITA
An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia
1 other identifier
interventional
100
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2013
Typical duration for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 9, 2015
October 1, 2015
2.6 years
June 6, 2013
October 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-Free Survival
3 year
Secondary Outcomes (1)
Transplantation-Related Mortality
3 year
Study Arms (2)
IDA-Etoposide Intensified Conditioning
EXPERIMENTALNon-IDA Conditioning
ACTIVE COMPARATORInterventions
Idarubicin: 15mg/m2/d: -8-\>-6d
TBI: 4.5 Gy/d, -5d, -4d
CY:60mg/kg/d, -3d, -2d
VP-16: 15mg/kg, -2d, -1d
Eligibility Criteria
You may qualify if:
- Age: 16 years to 65 years;
- Diagnosis of acute lymphoblastic leukemia;
- Patient receives allo-HSCT;
- The informed consent form has been signed;
You may not qualify if:
- Patient with severe cardiac dysfunction with less than 50% EF;
- Patient with severe lung dysfunction;
- 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;
- Patient with severe active infection;
- Patient with allergy history about suspected drug in conditioning regimen;
- Patient with other conditions considered unsuitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Department of Hematology, Union Hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010, China
Guangdong General Hospital
Guangzhou, Guangdong, 510030, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, 510317, China
Department of Hematology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
Department of Hematology, 1st Guangzhou People Hospital
Guangzhou, Guangdong, China
Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Zhongshan People Hospital,Guangdong
Zhongshan, Guangdong, 528403, China
Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Department of Hematology, Union Hospital, Huazhong Science and Technology
Wuhan, Hubei, 430022, China
Department of Hematology, Tongji Hospital, Huazhong Science and Technology
Wuhan, Hubei, 430030, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu, MD
Department of Hematologym, Nanfang Hospital, Southern Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 10, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 9, 2015
Record last verified: 2015-10