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

Study Overview
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Brief Summary
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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

Official Title
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Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: Y90 Ibritumomab Tiuxetan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Consolidation with Y90 Ibritumomab Tiuxetan<br>1. Consolidation with Y90 Ibritumomab Tiuxetan | Drug: Y90 Ibritumomab Tiuxetan<br>* Consolidation with Y90 Ibritumomab Tiuxetan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease |  | 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective clinical response rate (complete + partial). |  | 3 months | 
| Response conversion rate |  | 3 months | 
| Incidence of complete molecular responses |  | 3 months | 
| Response duration |  | 36 months | 
| Event-free survival. |  | 36 months | 
| Progression-free survival |  | 36 months | 
| Time to salvage therapy |  | 36 months | 
| Lymphoma-free or specific cause-free survival |  | 36 months | 
| Overall survival |  | 60 months | 
| Toxicity profile and safety of the consolidation |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular Lymphoma, High-risk FLIPI, R-CHOP, GOTEL, Partial, Complete, Response, Induction, Chemotherapy