Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis
- Sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Study ID
- NCT00945724
- Phase
- PHASE2
- Status
- Completed
Conditions
- Large B-cell Diffuse Lymphoma of Testis
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate — DRUGWeeks 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)
Study Details
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.
Key Dates
- Start date
- Sep 27, 2009
- Status verified
- May 2025
- Primary completion
- Jun 30, 2019
- Completion
- Sep 26, 2023
Study Design
- Enrollment
- 54 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: R-CHOP, Depocyte, Methotrexate
Primary Outcome Measure
Adverse Events Assessment [ 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 ]