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BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)

Primary Purpose

Non Hodgkin's Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Busulfan, Etoposide, Cytarabine, Melphalan

About this trial

This is an interventional treatment trial for Non Hodgkin's Lymphoma focused on measuring DLBCL, NHL

Eligibility Criteria

undefined - 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's lymphoma
Patients with histologically confirmed diffuse large B cell lymphoma at diagnosis
Patients treated with rituximab based regimen previously
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 (See Appendix II)
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 NHL 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 HospitalRecruiting
Asan Medical Center, University of UlsanRecruiting
Seoul National University HospitalRecruiting
Yeonsei University HospitalRecruiting
Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BuEAM: Experimental

Arm Description

BuEAM: Experimental 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: Drug: Busulfan, etoposide, cytarabine, and melphalan

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

NCT01063439

First Posted

February 4, 2010

Last Updated

December 1, 2010

Sponsor

Inje University

1. Study Identification

Unique Protocol Identification Number

NCT01063439

Brief Title

BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)

Official Title

Busulfan, Etoposide, Cytarabine and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With Diffuse Large B Cell Lymphoma (DLCBL) Previously Treated With Rituximab Based Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Inje University

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) including intravenous busulfan instead of BCNU of standard BEAM as a conditioning for autologous stem cell transplantation in patients with NHL.

Detailed Description

Among the high-dose conditioning regimens commonly used in patients with NHL are BEAM (BCNU, etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and cyclophosphamide), CBV (cyclophosphamide, carmustine, etoposide), and combination regimen with total body irradiation. Three-year progression free survival of patients with NHL 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 SCT have also been studied with ASCT 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 i.v. busulfan, cyclophosphamide, etoposide was found to be well tolerated and seemed to be effective in patients with aggressive NHL. Another prospective study for multiple myeloma patients showed that i.v. busulfan and melphalan conditioning regimen made no grade 3-4 non-hematological complication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Hodgkin's Lymphoma

Keywords

DLBCL, NHL

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: Experimental

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Busulfan, Etoposide, Cytarabine, Melphalan

Other Intervention Name(s)

BuEAM conditioning

Intervention Description

Busulfan 3.2 mg/kg/d for 2 days Etoposide 400 mg/m2/d for 2days Cytarabine 1 g/m2 for 2 days Melphalan 140 mg/m2 for 1 day

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

three year

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

three year

Title

Response rate according to the International Working Group criteria

Time Frame

after 2 month

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

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's lymphoma Patients with histologically confirmed diffuse large B cell lymphoma at diagnosis Patients treated with rituximab based regimen previously 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 (See Appendix II) 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 NHL 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

Won Sik Lee, Dr. PhD.

Phone

82-51-890-6407

wonsik112@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won Sik Lee, Dr. PhD.

Organizational Affiliation

Inje University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inje University Busan Paik Hospital

City

Busan

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Won Sik Lee, Dr. PhD.

Phone

+82-51-890-6407

wonsik112@gmail.com

First Name & Middle Initial & Last Name & Degree

Won Sik Lee, M.D. PhD.

Facility Name

Asan Medical Center, University of Ulsan

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Je Hwan Lee, M.D. Ph.D.

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung Soo Yoon, M.D. Ph.D.

Facility Name

Yeonsei University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Seok Kim, M.D. Ph.D.

Facility Name

Ulsan University Hospital

City

Ulsan

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hawk Kim, M.D. Ph. D.

12. IPD Sharing Statement

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BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)

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