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Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma

Primary Purpose

Non-Hodgkin Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Busulfan, etoposide, cytarabine, and melphalan

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non-Hodgkin lymphoma
Patients with histologically confirmed B cell lymphoma except for diffuse large B cell lymphoma at diagnosis
Patients who have not received therapy with high-dose chemotherapy and stem cell transplantation
Life expectation of at least 3 months
ECOG performance status ≤ 2
Adequate hepatic function (serum bilirubin less than 2.0 mg/dL, AST and ALT less than three times the upper normal limit)
Adequate renal function (serum creatinine less than 2.0 mg/dL).
Adequate cardiac function (ejection fraction ≥ 45% on MUGA scan or echocardiogram).
Adequate bone marrow function (ANC ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3).
All patients are fully informed about the nature and purpose of this study and informed consent should be given before the start of treatment. All patients should fully understand the right of trial abandon without any disadvantage

Exclusion Criteria:

Patients with central nervous system involvement of lymphoma
Patients positive for human immunodeficiency virus
Pregnant or breast feeding woman
Young woman without pregnancy test prior to treatment or pregnancy test reveals positive.
Young woman without a reliable and proper contraceptive method
Man being not willing to contraception
Concurrent history of neoplasm other than non-Hodgkin with life expectancy less than 3 months (except for curatively treated non-melanoma skin cancer or in-situ uterine cervix cancer).
History of clinically significant cardiac dysfunction (e.g. congestive heart failure, symptomatic coronary artery disease, medically uncontrolled arrhythmia) or myocardial infarction within 12 months
A psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Significant infection or uncontrolled bleeding
Enrollment of other clinical trials within 4 weeks prior to treatment
Any preexisting medical condition of sufficient severity to prevent full compliance with the study
Patient being not willing to or unable to obey study protocol

Sites / Locations

Inje University Busan Paik Hospital, Inje University College of MedicineRecruiting
Seoul National University Hospital, Seoul National University College of MedicineRecruiting
Severance Hospital, Yonsei University College of MedicineRecruiting
Asan Medical Center, University of Ulsan College of MedicineRecruiting
Ulsan University Hospital, University of Ulsan College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BuEAM

Arm Description

Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival

Response rate according to the International Working Group criteria

Adverse events

Pharmacogenetic study

Pharmacogenetic study for predictive or prognostic markers using blood samples

Full Information

NCT ID

NCT01178645

First Posted

August 3, 2010

Last Updated

August 22, 2014

Sponsor

Seoul National University Hospital

Collaborators

Inje University, Severance Hospital, Asan Medical Center, Ulsan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01178645

Brief Title

Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma

Official Title

Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Inje University, Severance Hospital, Asan Medical Center, Ulsan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity of busulfan, etoposide, cytarabine and melphalan (BuEAM) as a conditioning for autologous stem cell transplantation in patients with non-Hodgkin lymphoma.

Detailed Description

High-dose conditioning regimens commonly used in patients with non-Hodgkin lymphoma are BEAM (BCNU, etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and cyclophosphamide), CBV (cyclophosphamide, carmustine, and etoposide), and combination regimen with total body irradiation. Three-year progression free survival of patients with non-Hodgkin lymphoma received above high-dose chemotherapy followed by autologous stem cell rescue was reported as 40-50%, which is still unsatisfactory. Busulfan (Bu)-based preparative regimens, which are commonly used with allogeneic stem cell transplantation have also been studied with autologous stem cell transplantation for lymphomas. The development of intravenous busulfan achieved 100% bioavailability bypassing the oral route and increased safety and reliability of generating therapeutic busulfan levels, maximizing efficacy. Recently, one prospective study showed that a combination conditioning regimen of intravenous busulfan, cyclophosphamide, and etoposide was found to be well tolerated and seemed to be effective in patients with aggressive non-Hodgkin lymphoma. Another prospective study for patients with multiple myeloma showed that intravenous busulfan plus melphalan conditioning regimen made no grade 3-4 non-hematologic complication.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BuEAM

Arm Type

Experimental

Arm Description

Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day

Intervention Type

Drug

Intervention Name(s)

Busulfan, etoposide, cytarabine, and melphalan

Intervention Description

Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

After 3 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

After 3 years

Title

Response rate according to the International Working Group criteria

Time Frame

After 2 months

Title

Adverse events

Time Frame

From start of conditioning to discharge

Title

Pharmacogenetic study

Description

Pharmacogenetic study for predictive or prognostic markers using blood samples

Time Frame

After 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non-Hodgkin lymphoma Patients with histologically confirmed B cell lymphoma except for diffuse large B cell lymphoma at diagnosis Patients who have not received therapy with high-dose chemotherapy and stem cell transplantation Life expectation of at least 3 months ECOG performance status ≤ 2 Adequate hepatic function (serum bilirubin less than 2.0 mg/dL, AST and ALT less than three times the upper normal limit) Adequate renal function (serum creatinine less than 2.0 mg/dL). Adequate cardiac function (ejection fraction ≥ 45% on MUGA scan or echocardiogram). Adequate bone marrow function (ANC ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3). All patients are fully informed about the nature and purpose of this study and informed consent should be given before the start of treatment. All patients should fully understand the right of trial abandon without any disadvantage Exclusion Criteria: Patients with central nervous system involvement of lymphoma Patients positive for human immunodeficiency virus Pregnant or breast feeding woman Young woman without pregnancy test prior to treatment or pregnancy test reveals positive. Young woman without a reliable and proper contraceptive method Man being not willing to contraception Concurrent history of neoplasm other than non-Hodgkin with life expectancy less than 3 months (except for curatively treated non-melanoma skin cancer or in-situ uterine cervix cancer). History of clinically significant cardiac dysfunction (e.g. congestive heart failure, symptomatic coronary artery disease, medically uncontrolled arrhythmia) or myocardial infarction within 12 months A psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible. Significant infection or uncontrolled bleeding Enrollment of other clinical trials within 4 weeks prior to treatment Any preexisting medical condition of sufficient severity to prevent full compliance with the study Patient being not willing to or unable to obey study protocol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sung-Soo Yoon

Phone

+82-2-2072-3079

ssysmc@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Won Sik Lee

Phone

+82-51-890-6407

drlee112@hanafos.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung-Soo Yoon

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inje University Busan Paik Hospital, Inje University College of Medicine

City

Busan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Won Sik Lee

Phone

+82-51-890-6407

drlee112@hanafos.com

First Name & Middle Initial & Last Name & Degree

Won Sik Lee

Facility Name

Seoul National University Hospital, Seoul National University College of Medicine

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung-Soo Yoon

Phone

+82-2-2072-3079

ssysmc@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Ji-Won Kim

Phone

+82-11-9010-0427

werbinig@gmail.com

First Name & Middle Initial & Last Name & Degree

Byoung Kook Kim

First Name & Middle Initial & Last Name & Degree

Seonyang Park

First Name & Middle Initial & Last Name & Degree

Sung-Soo Yoon

First Name & Middle Initial & Last Name & Degree

Inho Kim

Facility Name

Severance Hospital, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Seok Kim

hemakim@yuhs.ac

First Name & Middle Initial & Last Name & Degree

Jin Seok Kim

Facility Name

Asan Medical Center, University of Ulsan College of Medicine

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Je Hwan Lee

jhlee3@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

Je Hwan Lee

Facility Name

Ulsan University Hospital, University of Ulsan College of Medicine

City

Ulsan

ZIP/Postal Code

682-714

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hawk Kim

First Name & Middle Initial & Last Name & Degree

Hawk Kim

12. IPD Sharing Statement

Learn more about this trial

Study of Busulfan, Etoposide, Cytarabine, and Melphalan (BuEAM) Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat B Cell Lymphoma Except for Diffuse Large B Cell Lymphoma

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