Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma (GOTEL-FL1LC)

Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Status and phase

Unknown

Phase 2

Conditions

Follicular Lymphoma

Treatments

Drug: Y90 Ibritumomab Tiuxetan

Study type

Interventional

Funder types

Other

Identifiers

NCT00722930

Eudra-CT 2007-003091-19

GOTEL-FL1LC-0701

Details and patient eligibility

About

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

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).