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

NCT01063439 | Unknown Phase 2

• 1 other identifier: BuEAM-DLBCL
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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.

Conditions

Non Hodgkin's Lymphoma

Keywords

DLBCL; NHL

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  three year

Secondary Outcomes (4)

• overall survival

  three year

• Response rate according to the International Working Group criteria

  after 2 month

• Adverse events

  From start of conditioning to discharge

• •Pharmacogenetic study

  After 3 years

Study Arms (1)

BuEAM: Experimental

EXPERIMENTAL

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

Drug: Busulfan, Etoposide, Cytarabine, Melphalan

Interventions

Busulfan, Etoposide, Cytarabine, Melphalan DRUG

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

Also known as: BuEAM conditioning

BuEAM: Experimental

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead

Study Sites (5)

Inje University Busan Paik Hospital

Busan, Busan, South Korea

RECRUITING

Asan Medical Center, University of Ulsan

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Yeonsei University Hospital

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Busulfan; Etoposide; Cytarabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Won Sik Lee, Dr. PhD.

  Inje University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Sik Lee, Dr. PhD.

CONTACT

82-51-890-6407; wonsik112@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 2, 2010

Record last verified: 2010-08

Locations

KR (5)