Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas (073)
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
Drug: CEEP regimen
Procedure: Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas|
- Complete response [ Time Frame: end of treatment ] [ Designated as safety issue: Yes ]
- overall survival disease free survival [ Time Frame: 10 years after treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 1994|
|Study Completion Date:||February 2009|
|Primary Completion Date:||July 1999 (Final data collection date for primary outcome measure)|
Drug: CEEP regimen
The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4.
The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869284
|Tours, France, 37000|
|Principal Investigator:||Noël MILPIED, MDPD||Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS|