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Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL) (BME)

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Busulfan
Melphalan
Etoposide
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Transplantation Conditioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Histologically confirmed aggressive NHL
  2. Mantle cell lymphoma
  3. salvage chemotherapy sensitive relapse/refractory NHL
  4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
  5. Age; 18-65
  6. Adequate renal function: serum creatinine ≤ 1.5mg/dL
  7. Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value

Exclusion criteria

  1. low grade NHL
  2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri

  3. Other serious illness or medical conditions

    • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
    • History of significant neurological or psychiatric disorders
    • Active uncontrolled infection (viral, bacterial or fungal infection)
  4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  5. HIV (+)
  6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period

Sites / Locations

  • Soonchunhyang University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

busulfan melphalan etoposide

Arm Description

busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Outcomes

Primary Outcome Measures

rate of event free survival
calculate from the date of ASCT until the time of disease progression, relapse, or death

Secondary Outcome Measures

rate of event free survival
calculate from the date of ASCT until the time of death from any causes
rate of regimen related toxicity
calculate toxicities

Full Information

First Posted
February 16, 2010
Last Updated
January 2, 2019
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03792815
Brief Title
Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)
Acronym
BME
Official Title
Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
Detailed Description
Treatment: busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Transplantation Conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
busulfan melphalan etoposide
Arm Type
Experimental
Arm Description
busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2
Intervention Type
Drug
Intervention Name(s)
Busulfan
Other Intervention Name(s)
Busulfex
Intervention Description
busulfan 3.2mg/kg iv on day -8, -7, and -6,
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran
Intervention Description
melphalan 50mg/m2/day i.v. on day -3 and -2
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
etoposide 400 mg/m2 i.v. on day -5 and -4
Primary Outcome Measure Information:
Title
rate of event free survival
Description
calculate from the date of ASCT until the time of disease progression, relapse, or death
Time Frame
from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years
Secondary Outcome Measure Information:
Title
rate of event free survival
Description
calculate from the date of ASCT until the time of death from any causes
Time Frame
at least 2 years
Title
rate of regimen related toxicity
Description
calculate toxicities
Time Frame
up to 6 months

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 Histologically confirmed aggressive NHL Mantle cell lymphoma salvage chemotherapy sensitive relapse/refractory NHL Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2. Age; 18-65 Adequate renal function: serum creatinine ≤ 1.5mg/dL Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value Exclusion criteria low grade NHL Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri Other serious illness or medical conditions Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry History of significant neurological or psychiatric disorders Active uncontrolled infection (viral, bacterial or fungal infection) Pregnant or lactating women, women of childbearing potential not employing adequate contraception HIV (+) Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Ho Won, Professor
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Hospital
City
Seoul
ZIP/Postal Code
140-743
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)

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