Status:
COMPLETED
Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Soonchunhyang University Hospital
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 No...
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
Eligibility Criteria
Inclusion
- Inclusion criteria
- Histologically confirmed aggressive NHL
- Mantle cell lymphoma
- salvage chemotherapy sensitive relapse/refractory NHL
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
- Age; 18-65
- Adequate renal function: serum creatinine ≤ 1.5mg/dL
- Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value
- Exclusion criteria
- low grade NHL
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- 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)
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- HIV (+)
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03792815
Start Date
October 1 2009
End Date
September 1 2013
Last Update
January 4 2019
Active Locations (1)
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1
Soonchunhyang University Hospital
Seoul, South Korea, 140-743