NCT03794167

BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma

Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Detailed description

Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies. The investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL. Therefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.

Conditions

• Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Busulfan	busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
DRUG	Cyclophosphamide	cyclophosphamide 50mg/kg/day i.v. on days -3 and -2
DRUG	Etoposide	etoposide 400mg/m2 day i.v. on days -5 and -4
DRUG	Melphalan	melphalan 50mg/m2/day i.v. on days -3 and -2

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-05-30
• Completion: 2018-11-30
• First posted: 2019-01-04
• Last updated: 2019-01-07

Locations

1 site across 1 country: South Korea