Overview

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

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Soonchunhyang University Hospital
Treatments:
Busulfan
Etoposide
Etoposide phosphate
Melphalan
Criteria
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