Phase II, multi-centric, open-label, study. Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.
Initial treatment: 6 courses of CHOP-R 14 with evaluation of response before C4 (observation of no change or progression at this time will get the patient off study). Consolidation : fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Consolidation : Fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8)
Chu/Clcc Nantes
Nantes, France
Event free survival (EFS)
Time frame: EFS post treatment (at 2 years)
Objective disease response (CR, CRu and PR), SD and disease progression
Time frame: OS after treatment
Duration of response
Time frame: Time interval from the date on which a response (CR, CRu and PR)
Time to disease progression
Time frame: Time interval from the date from initial of study treatment until the date on which disease progression is documented
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