Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
- Sponsor
- Lymphoma Study Association
- Study ID
- NCT00689169
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lymphoma, Large Cell, Diffuse
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) — DRUGZevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2
- ASCT — PROCEDUREASCT : D0
- Rituximab — DRUGRituximab 250 mg/m² :D-21 D-14
Study Details
The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma
Key Dates
- Start date
- Aug 31, 2007
- Status verified
- Mar 2018
- Primary completion
- Jan 31, 2011
- Completion
- Jan 31, 2014
Study Design
- Enrollment
- 75 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ExperimentalZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab
Primary Outcome Measure
Event free survival (EFS): events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy [ Time Frame: 2 years ]