BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma

Official Title
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Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma

Conditions
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Lymphoma, Non-Hodgkin

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically diagnosed non-Hodgkin's lymphoma 16 ≤ Age ≤ 65 years Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA) Adequate kidney function with serum creatinine< 2.0 mg/dL Adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, Aspartate aminotransferase(AST)/ Alanine aminotransaminase(ALT) lower than 3 times the normal upper limit. In case of DLBCL liver invasion; serum bilirubin lower than 5 times the normal upper limit, AST/ALT lower than 5 times the normal upper limit. Adequate bone marrow function with absolute neutrophil count ≥ 1,500/µL; platelets ≥ 75,000/µL; hemoglobin ≥ 9.0 g/dL Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients Candidate for ASCT Exclusion Criteria: Positive serology for HIV, hepatitis C virus(HCV) If the hepatitis B virus(HBV) patient was administrated prophylactic antiviral agents. It would be eligible following the judgment of the investigator Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial. Patients with serious or uncontrolled medical condition; 1) Abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) Previous history of serious neurological or psychiatric disease; 3) Acute, severe active infection requiring immediate treatment(Virus, Bacteria, Fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or Forced expiratory volume 1 sec(FEV1)<0.8 L less than the test of pulmonary function at rest; 5) If there are other diseases that are deemed inappropriate as a target of the present clinical trial following the Investigator's judgment; 6) Congenital or acquired bleeding disorders Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy) Allergic to the investigational drug Patients who have difficulty understanding the informed consent form or patients who did not give consent Serum bilirubin upper than 2 times the normal upper limit Major surgery procedure within 30 days prior to start of investigational treatment Patients vaccinated against yellow fever

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, Etoposide, Bendamustine<br>All patients will receive the conditioning regimen followed by autologous stem cell transplantation. | Drug: Busulfan<br>* Busulfan 0.8 mg/kg four times per day from day -7 to day -5<br>Drug: Etoposide<br>* Etoposide 400 mg/m2 from day -5 to day -4<br>Drug: Bendamustine<br>* Bendamustine 200 mg/m2 starting dose on day -3 and -2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 1 year after ASCT | 
| Progression-free survival |  | 3 years after ASCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year and 3 year after ASCT | 
| Complete response rate |  | 1 year and 3 year after ASCT | 
| Incidence of adverse events |  | 1 year and 3 year after ASCT |