The promising activity of Bortezomib as single agent in low grade lymphoma patients in small studies has led to a number of larger multicenter trials with Bortezomib in combination with Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma.
This is a open label, non randomized, phase II , multicenter, prospective trial to evaluate the efficacy and safety of the combination of bortezomib and rituximab in patients with relapsed or refractory rituximab naïve or sensitive indolent non-follicular and mantle cell non-Hodgkin's lymphoma. Despite of the availability of treatment for this disease, this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the clinical outcome and prognosis of relapsed indolent lymphoma. This study is designed for patients not eligible for high-dose chemotherapy and autologous stem cells transplantation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Rituximab 375 mg/m2 as slow iv infusion day 1-8-15-22.Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
VELCADE 1,6 mg/m2 iv bolus days 1-8-15-22 (Velcade will be administrated prior of Rituximab infusion).Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
Ospedale Cardinale Panico
Tricase, Lecce, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
To demonstrate a statistical benefit in overall response rate (ORR) of the Bortezomib/Rituximab association in this study 3/13 or fewer responses are observed during the first stage then the trail is stopped early
Time frame: 1 year
If 12/43 or fewer responses are observed by the end of the trail, then no further investigation of this regimen is warranted
Time frame: 4 years
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Istituto per la ricerca e la cura del cancro
Candiolo, Torino, Italy
Ospedale Civico
Chivasso, Torino, Italy
Stabilimento Ospedaliero
Cirié, Torino, Italy
ASO SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Oncologico
Bari, Italy
Policlinico S.Orsola Malpighi
Bologna, Italy
Spedali Civili
Brescia, Italy
Ospedale Armando Businco
Cagliari, Italy
...and 12 more locations