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

Soonchunhyang University Hospital51 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin's Lymphoma

Interventions

BusulfanDRUG

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

MelphalanDRUG

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

EtoposideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Soonchunhyang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

rate of event free survival

calculate from the date of ASCT until the time of disease progression, relapse, or death

Time frame: from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years

Secondary Outcomes

rate of event free survival

calculate from the date of ASCT until the time of death from any causes

Time frame: at least 2 years

rate of regimen related toxicity

calculate toxicities

Time frame: up to 6 months

Data from ClinicalTrials.gov

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