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

Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03792815

Acronym

BME

Enrollment

Registered

2019-01-03

Start date

2009-10-31

Completion date

2013-09-30

Last updated

2019-01-04

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

Conditions

Non-Hodgkin's Lymphoma

Keywords

Transplantation Conditioning

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

Interventions

DRUGBusulfan

busulfan 3.2mg/kg iv on day -8, -7, and -6,

DRUGMelphalan

melphalan 50mg/m2/day i.v. on day -3 and -2

DRUGEtoposide

etoposide 400 mg/m2 i.v. on day -5 and -4

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Histologically confirmed aggressive NHL 2. Mantle cell lymphoma 3. salvage chemotherapy sensitive relapse/refractory NHL 4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2. 5. Age; 18-65 6. Adequate renal function: serum creatinine ≤ 1.5mg/dL 7. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value & Bilirubin \< 2 X upper normal value

Exclusion criteria

1. low grade NHL 2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 3. Other serious illness or medical conditions * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * History of significant neurological or psychiatric disorders * Active uncontrolled infection (viral, bacterial or fungal infection) 4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 5. HIV (+) 6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026