BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed Description
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Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.

Official Title
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Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Conditions
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Autologous Hematopoietic Stem Cell Transplantation, Diffuse Large B-cell Lymphoma, Conditioning

Intervention / Treatment
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* Drug: Busulfan (BU)
* Drug: Cyclophosphamide (CY)
* Drug: Etoposide (VP-16)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diffuse large B-cell lymphoma patients Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting of peripheral blood stem cells and receiving one cycle of chemotherapy Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUCY+VP-16<br>For DLBCL patients undergoing auto-HSCT，BUCY+VP-16 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)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>Drug: Etoposide (VP-16)<br>* Etoposide was administered at 15 mg/kg/day on days -3 to -2.<br>|
| Active Comparator: BUCY<br>For DLBCL patients undergoing auto-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2. | Drug: Busulfan (BU)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate | relapse rate | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | disease-free survival (DFS) | 2 year | 
| OS | overall survival (OS) | 2 year | 
| TRM | transplant-related mortality (TRM) | 2 year |