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

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ClinicalTrials.gov Identifier: NCT02836639
Recruitment Status : Unknown
Verified July 2016 by Ho-Jin Shin, Pusan National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ho-Jin Shin, Pusan National University Hospital

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

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Busulfan Drug: Etoposide Drug: Bendamustine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019


Arm Intervention/treatment
Experimental: Busulfan, Etoposide, Bendamustine
All patients will receive the conditioning regimen followed by autologous stem cell transplantation.
Drug: Busulfan
Busulfan 0.8 mg/kg four times per day from day -7 to day -5

Drug: Etoposide
Etoposide 400 mg/m2 from day -5 to day -4

Drug: Bendamustine
Bendamustine 200 mg/m2 starting dose on day -3 and -2




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year after ASCT ]
  2. Progression-free survival [ Time Frame: 3 years after ASCT ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year and 3 year after ASCT ]
  2. Complete response rate [ Time Frame: 1 year and 3 year after ASCT ]
  3. Incidence of adverse events [ Time Frame: 1 year and 3 year after ASCT ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically diagnosed non-Hodgkin's lymphoma
  2. 16 ≤ Age ≤ 65 years
  3. Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)
  4. Adequate kidney function with serum creatinine< 2.0 mg/dL
  5. 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.
  6. Adequate bone marrow function with absolute neutrophil count ≥ 1,500/µL; platelets ≥ 75,000/µL; hemoglobin ≥ 9.0 g/dL
  7. Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients
  8. Candidate for ASCT

Exclusion Criteria:

  1. 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
  2. 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.
  3. 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
  4. Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)
  5. Allergic to the investigational drug
  6. Patients who have difficulty understanding the informed consent form or patients who did not give consent
  7. Serum bilirubin upper than 2 times the normal upper limit
  8. Major surgery procedure within 30 days prior to start of investigational treatment
  9. Patients vaccinated against yellow fever

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836639


Contacts
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Contact: Jieon Lee +82-51-240-7053 jieon@pnuh.co.kr

Locations
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Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of
Contact: Hojin Shin       hojinja@hanmail.net   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
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Principal Investigator: Hojin Shin Pusan National Universty Hospital
Publications:
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Responsible Party: Ho-Jin Shin, Professor department of hematooncology, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02836639    
Other Study ID Numbers: BEB
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide
Busulfan
Bendamustine Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Myeloablative Agonists