Non-hodgkin Lymphoma
Conditions
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 patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
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 malignancies. The investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL. Therefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.
Interventions
DRUGBusulfan
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
DRUGCyclophosphamide
cyclophosphamide 50mg/kg/day i.v. on days -3 and -2
DRUGEtoposide
etoposide 400mg/m2 day i.v. on days -5 and -4
DRUGMelphalan
melphalan 50mg/m2/day i.v. on days -3 and -2
Sponsors
Soonchunhyang University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed aggressive NHL 2. Mantle cell lymphoma 3. salvage chemotherapy sensitive relapse/refractory NHL or high risk NHL with remission in induction chemotherapy 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 progression free survival | 2 years | calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall survival | 2 years | calculate from the date of ASCT until the time of death from any causes |
| Rate of regimen related toxicity | 6 months | calculate toxicities frequency |
Countries
South Korea
Outcome results
None listed