BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT
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|ClinicalTrials.gov Identifier: NCT03733327|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Central Nervous System Lymphoma Autologous Hematopoietic Stem Cell Transplantation Conditioning||Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Drug: Etoposide (VP-16)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
For PCNSL patients undergoing auto-HSCT，BUCYE conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/ day on days -3 and -2.
Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days−7 to −4.
Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days −3 to −2.
Drug: Etoposide (VP-16)
Etoposide was administered at 15 mg/kg/day on days −3 to −2.
- OS [ Time Frame: 2 year ]overall survival (OS)
- DFS [ Time Frame: 2 year ]disease-free survival (DFS)
- relapse rate [ Time Frame: 2 year ]relapse rate
- TRM [ Time Frame: 2 year ]transplant-related mortality (TRM)
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): NCT03733327
|Contact: Qifa Liuemail@example.com|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Li Xuan +86-020-62787883 firstname.lastname@example.org|
|Principal Investigator: Qifa Liu|
|Principal Investigator:||Qifa Liu||Nanfang Hospital of Southern Medical University|