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BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma (CISL)

Primary Purpose

Non-hodgkin Lymphoma

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

About this trial

This is an interventional treatment trial for Non-hodgkin Lymphoma

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 or high risk NHL with remission in induction chemotherapy
  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

  • Jong-Ho Won

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

busulfan cyclophosphamide etoposide

busulfan melphalan etoposide

Arm Description

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4

busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4

Outcomes

Primary Outcome Measures

Rate of progression free survival
calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death

Secondary Outcome Measures

Rate of overall survival
calculate from the date of ASCT until the time of death from any causes
Rate of regimen related toxicity
calculate toxicities frequency

Full Information

First Posted
January 3, 2019
Last Updated
January 3, 2019
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03794167
Brief Title
BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma
Acronym
CISL
Official Title
Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
Detailed Description
Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies. The investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL. Therefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
busulfan cyclophosphamide etoposide
Arm Type
Experimental
Arm Description
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4
Arm Title
busulfan melphalan etoposide
Arm Type
Active Comparator
Arm Description
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4
Intervention Type
Drug
Intervention Name(s)
Busulfan
Other Intervention Name(s)
Busulfex
Intervention Description
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
cyclophosphamide 50mg/kg/day i.v. on days -3 and -2
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
etoposide 400mg/m2 day i.v. on days -5 and -4
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran
Intervention Description
melphalan 50mg/m2/day i.v. on days -3 and -2
Primary Outcome Measure Information:
Title
Rate of progression free survival
Description
calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rate of overall survival
Description
calculate from the date of ASCT until the time of death from any causes
Time Frame
2 years
Title
Rate of regimen related toxicity
Description
calculate toxicities frequency
Time Frame
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 or high risk NHL with remission in induction chemotherapy 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
Jong-Ho Won
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma

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