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

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Busulfan
* Drug: Melphalan
* Drug: Etoposide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: busulfan melphalan etoposide<br>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 | Drug: Busulfan<br>* busulfan 3.2mg/kg iv on day -8, -7, and -6,<br>* Other names: Busulfex;Drug: Melphalan<br>* melphalan 50mg/m2/day i.v. on day -3 and -2<br>* Other names: Alkeran;Drug: Etoposide<br>* etoposide 400 mg/m2 i.v. on day -5 and -4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of event free survival | calculate from the date of ASCT until the time of disease progression, relapse, or death | from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of event free survival | calculate from the date of ASCT until the time of death from any causes | at least 2 years | 
| rate of regimen related toxicity | calculate toxicities | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation Conditioning