BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Conditioning; Primary Central Nervous System Lymphoma; Autologous Hematopoietic Stem Cell Transplantation

Treatments: Drug: Busulfan (BU); Drug: Etoposide (VP-16); Drug: Cyclophosphamide (CY)

Study type: Interventional

Funder types: Other

Identifiers

NCT03733327

BUCYE-PCNSL-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BUCYE

Experimental group

Description:

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.

Treatment:

Drug: Etoposide (VP-16)

Drug: Cyclophosphamide (CY)

Drug: Busulfan (BU)