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

July 14, 2016 updated by: Ho-Jin Shin, Pusan National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Hojin Shin, Pusan National Universty Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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