Status:
COMPLETED
BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma
Lead Sponsor:
Soonchunhyang University Hospital
Conditions:
Non-hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patient...
Detailed Description
Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignanci...
Eligibility Criteria
Inclusion
- Histologically confirmed aggressive NHL
- Mantle cell lymphoma
- salvage chemotherapy sensitive relapse/refractory NHL or high risk NHL with remission in induction chemotherapy
- 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
- 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 -
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03794167
Start Date
June 1 2012
End Date
November 30 2018
Last Update
January 7 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jong-Ho Won
Seoul, South Korea, 04401