This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Weeks 1-15: * 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days * Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle * IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4\&5 of R-CHOP Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Spedali Civili
Brescia, Italy
Adverse Events Assessment
Number of patients who withdrew the treatment due to adverse event
Time frame: From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group
5 Year Cumulative Incidence of Progressions
Percentage of patients with disease progression after achieving a remission
Time frame: From the first documented response to relapse until 5 years from study entry
5 Years Progression Free Survival (PFS)
Percentage of patients free from disease progression after 5 years from study entry
Time frame: From study entry until 5 years after
5 Years Overall Survival (OS)
Percentage of patients alive after 5 years from study entry
Time frame: From study entry until 5 years after
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ematologia Ospedale Businco
Cagliari, Italy
S. Martino Hospital
Genova, Italy
European Institute of Oncology
Milan, Italy
San Raffaele H Scientific Institute
Milan, Italy
Policlinico
Modena, Italy
A.O. San Gerardo
Monza, Italy
AOU Maggiore della Carità
Novara, Italy
S. Matteo
Pavia, Italy
...and 12 more locations