Lymphoma
Conditions
Keywords
High-dose chemotherapy, aggressive NHL, high-risk, PBSC
Brief summary
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
Detailed description
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years
Interventions
cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* patients aged from 15 to 60 years * previously untreated * histologically proven aggressive NHL * high aa-IPI (equal to 3) * proper underlying organ function
Exclusion criteria
* transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response | end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| overall survival disease free survival | 10 years after treatment |
Countries
France