Clinical trial · Interventional
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
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
NCT01178645CI-TRIAL-00015471unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan, etoposide, cytarabine, and melphalan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BuEAM
- 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
- interventionNames
- Drug: Busulfan, etoposide, cytarabine, and melphalan
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- After 3 years
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- After 3 years
- measure
- Response rate according to the International Working Group criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.