To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Day -21: rituximab. 250 mg/m2 iv Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi). Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1.
Hospital Universitario de Alicante
Alicante, Alicante, Spain
H. de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Disease clinical response to treatment - complete response rate.
Time frame: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation
Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.
Time frame: 36 months
Overall response rate (complete + partial response)
Time frame: 36 month
Progression-free-survival
Time frame: 36 month
Overall survival
Time frame: 96 months
Post-transplantation haematological and immunological reconstitution
Time frame: Until post-transplantation day +100
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Instituto Catalán de Oncología,
Barcelona, Barcelona, Spain
H.Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
H.U. Marqués de Valdecilla
Santander, Cantabria, Spain
H. Reina Sofía
Córdoba, Córdoba, Spain
Clínica Puerta de Hierro,
Madrid, Madrid, Spain
H.U. 12 de Octubre,
Madrid, Madrid, Spain
H.U. Gregorio Marañón,
Madrid, Madrid, Spain
H.U. La Paz
Madrid, Madrid, Spain
...and 8 more locations