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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03229616

Enrollment

122

Registered

2017-07-25

Start date

2017-07-05

Completion date

2020-06-30

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

DRUGBusulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

DRUGCyclophosphamide (CY)

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

DRUGEtoposide (VP-16)

Etoposide was administered at 15 mg/kg/day on days -3 to -2.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
relapse rate	2 year	relapse rate

Secondary

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

Countries

China

Contacts

Primary ContactQifa Liu

liuqifa628@163.com+862061641611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026