Trials / Completed
CompletedNCT00689169
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
Targeted Intensification by a Preparative Regimen for Patients With High-grade B-Cell Lymphoma Utilizing Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-dose BEAM Followed by Autologous Stem Cell Transplantation (ASCT)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Lymphoma Study Association · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) | Zevalin 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 |
| PROCEDURE | ASCT | ASCT : D0 |
| DRUG | Rituximab | Rituximab 250 mg/m² :D-21 D-14 |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2011-01-01
- Completion
- 2014-01-01
- First posted
- 2008-06-03
- Last updated
- 2018-03-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00689169. Inclusion in this directory is not an endorsement.