BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Busulfan
Etoposide
Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin
Eligibility Criteria
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
Sites / Locations
- Pusan National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Busulfan, Etoposide, Bendamustine
Arm Description
All patients will receive the conditioning regimen followed by autologous stem cell transplantation.
Outcomes
Primary Outcome Measures
Progression-free survival
Progression-free survival
Secondary Outcome Measures
Overall survival
Complete response rate
Incidence of adverse events
Full Information
NCT ID
NCT02836639
First Posted
June 27, 2016
Last Updated
July 14, 2016
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02836639
Brief Title
BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma
Official Title
Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Busulfan, Etoposide, Bendamustine
Arm Type
Experimental
Arm Description
All patients will receive the conditioning regimen followed by autologous stem cell transplantation.
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
Busulfan 0.8 mg/kg four times per day from day -7 to day -5
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide 400 mg/m2 from day -5 to day -4
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
Bendamustine 200 mg/m2 starting dose on day -3 and -2
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
1 year after ASCT
Title
Progression-free survival
Time Frame
3 years after ASCT
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year and 3 year after ASCT
Title
Complete response rate
Time Frame
1 year and 3 year after ASCT
Title
Incidence of adverse events
Time Frame
1 year and 3 year after ASCT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jieon Lee
Phone
+82-51-240-7053
Email
jieon@pnuh.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hojin Shin
Organizational Affiliation
Pusan National Universty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hojin Shin
Email
hojinja@hanmail.net
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21816830
Citation
Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.
Results Reference
background
PubMed Identifier
24432893
Citation
Shin HJ, Lee WS, Lee HS, Kim H, Lee GW, Song MK, Kim JS, Yhim HY, Chung JS. Busulfan-containing conditioning regimens are optimal preparative regimens for autologous stem cell transplant in patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2014 Nov;55(11):2490-6. doi: 10.3109/10428194.2014.882504. Epub 2014 Mar 7.
Results Reference
background
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BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma
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