To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Consolidation with Y90 Ibritumomab Tiuxetan
Hospital Virgen de las Nieves
Granada, Granada, Spain
ACTIVE_NOT_RECRUITINGClinia Puerta de Hierro
Madrid, Madrid, Spain
RECRUITINGClínica Ruber Internacional
Madrid, Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital Virgen de la Victoria
Málaga, Malaga, Spain
ACTIVE_NOT_RECRUITINGComplejo Hospitalario de Pontevedra
Pontevedra, Pontevedra, Spain
ACTIVE_NOT_RECRUITINGInstituto Oncológico San Sebastián
Donostia / San Sebastian, San Sebastián, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Virgen Macarena
Seville, Sevilla, Spain
ACTIVE_NOT_RECRUITINGHospital Sant Joan de Reus
Reus, Tarragona, Spain
ACTIVE_NOT_RECRUITINGHospital Virgen de la Salud de Toledo
Toledo, Toledo, Spain
ACTIVE_NOT_RECRUITING...and 1 more locations
CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease
Time frame: 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter
Objective clinical response rate (complete + partial).
Time frame: 3 months
Response conversion rate
Time frame: 3 months
Incidence of complete molecular responses
Time frame: 3 months
Response duration
Time frame: 36 months
Event-free survival.
Time frame: 36 months
Progression-free survival
Time frame: 36 months
Time to salvage therapy
Time frame: 36 months
Lymphoma-free or specific cause-free survival
Time frame: 36 months
Overall survival
Time frame: 60 months
Toxicity profile and safety of the consolidation
Time frame: 60 months
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