BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03733327

Enrollment

Registered

2018-11-07

Start date

2018-11-30

Completion date

2021-10-31

Last updated

2018-11-07

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

Conditions

Primary Central Nervous System Lymphoma, Autologous Hematopoietic Stem Cell Transplantation, Conditioning

Brief summary

The purpose of this study is to evaluate the safety and efficacy of BUCYE conditioning regimens in primary central nervous system lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed description

The prognosis of patients with primary central nervous system lymphoma (PCNSL) is poor. Recent studies have demonstrated that autologous hematopoietic stem cell transplantation (auto-HSCT) could improve the prognosis of these patients. However, the optimal conditioning regimen of auto-HSCT remains unclear. In this study, the investigators evaluated the safety and efficacy of BUCYE conditioning regimens in PCNSL undergoing auto-HSCT.

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

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Primary central nervous system lymphoma patients * Achieving CR or PR, then mobilizing and collecting of peripheral blood stem cells

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
OS	2 year	overall survival (OS)

Secondary

Measure	Time frame	Description
DFS	2 year	disease-free survival (DFS)
relapse rate	2 year	relapse rate
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