BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Central Nervous System Lymphoma Autologous Hematopoietic Stem Cell Transplantation Conditioning

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BUCYE

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.

Group Type EXPERIMENTAL

Busulfan (BU)

Intervention Type DRUG

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

Cyclophosphamide (CY)

Intervention Type DRUG

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

Etoposide (VP-16)

Intervention Type DRUG

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

Interventions

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Busulfan (BU)

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

Intervention Type DRUG

Cyclophosphamide (CY)

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

Intervention Type DRUG

Etoposide (VP-16)

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No