BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma

Soonchunhyang University Hospital75 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-hodgkin Lymphoma

Interventions

BusulfanDRUG

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6

CyclophosphamideDRUG

cyclophosphamide 50mg/kg/day i.v. on days -3 and -2

EtoposideDRUG

etoposide 400mg/m2 day i.v. on days -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 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 -

Locations (1)

Jong-Ho Won

Seoul, South Korea

Outcomes

Primary Outcomes

Rate of progression free survival

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

Time frame: 2 years

Secondary Outcomes

Rate of overall survival

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

Time frame: 2 years

Rate of regimen related toxicity

calculate toxicities frequency

Time frame: 6 months

Data from ClinicalTrials.gov

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