Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy
- Signature of the written informed consent by the subject or his/her legal
representative before initiation of any trial specific procedure.
- Patients older than 18.
- Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO
- High-risk patients according to FLIPI before initiation of induction chemotherapy.
- Stage II-IV prior to initiation of induction treatment, or any stage in patients with
grade 3 follicular lymphoma.
- Complete or partial response to the induction scheme.
- ECOG scale performance status 0 - 2.
- Life expectancy greater than 3 months.
- In women of childbearing age, use of a reliable contraceptive method.
- A suitable bone marrow reserve:
- Lower than 25% Bone marrow infiltration by lymphoma.
- Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
- Suitable hepatic, renal and cardiac function:
- creatinine <2,5 x UNL (upper normality limit).
- bilirubin or ALT/AST < 2,5 x UNL
- Patients with no objective clinical response to induction chemotherapy.
- > 25% bone marrow infiltration following induction chemotherapy.
- Platelets < 100,000 before radioimmunotherapy.
- Severe and/or uncontrolled concomitant disease:
- Hepatic, renal, cardiovascular, neurological or metabolic disease.
- Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of
myocardial infarction or angor, or major ventricular arrhythmia.
- Positive regarding HBV, HCV, HIV.
- Active acute or chronic infection.
- Social, psychic or geographic disability to satisfy any of the treatment schemes.
- Pregnant and/or breastfeeding women, or adult patients of childbearing age who are
not using a safe birth control device throughout the study treatment and at least 12
- Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to
the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a
history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other