Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Busulfan; Drug: Melphalan; Drug: Etoposide

• Registration Number: NCT03792815
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

The investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Detailed Description

Treatment:

busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-16
• Primary Completion: 2011-11
• Study Completion: 2013-09
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-02
• Study First Posted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
busulfan melphalan etoposide	Busulfan	busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2
busulfan melphalan etoposide	Etoposide	busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2
busulfan melphalan etoposide	Melphalan	busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Primary Outcome Measures

Name	Time	Method
rate of event free survival	from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years	calculate from the date of ASCT until the time of disease progression, relapse, or death

Secondary Outcome Measures

Name	Time	Method
rate of event free survival	at least 2 years	calculate from the date of ASCT until the time of death from any causes
rate of regimen related toxicity	up to 6 months	calculate toxicities

Trial Locations

Locations (1)

Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of