Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

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 classification.
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

Exclusion Criteria:

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 months thereafter.
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 anthracyclines, cytarabine).