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

Sponsor
Pusan National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02836639
Collaborator
(none)
20
Enrollment
1
Location
1
Arm

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [1 year after ASCT]

  2. Progression-free survival [3 years after ASCT]

Secondary Outcome Measures

  1. Overall survival [1 year and 3 year after ASCT]

  2. Complete response rate [1 year and 3 year after ASCT]

  3. Incidence of adverse events [1 year and 3 year after ASCT]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pusan National University Hospital Busan Korea, Republic of

Sponsors and Collaborators

  • Pusan National University Hospital

Investigators

  • Principal Investigator: Hojin Shin, Pusan National Universty Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ho-Jin Shin, Professor department of hematooncology, Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT02836639
Other Study ID Numbers:
  • BEB
First Posted:
Jul 19, 2016
Last Update Posted:
Jul 19, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Etoposide
Busulfan
Bendamustine Hydrochloride

Study Results

No Results Posted as of Jul 19, 2016