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

Phase 2

• Conditions: Follicular Lymphoma
• Interventions: Drug: Y90 Ibritumomab Tiuxetan

• Registration Number: NCT00722930
• Lead Sponsor: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Last Update Submitted: 2008-07-25
• Study First Posted: 2008-07-28
• Last Update Posted: 2008-07-28
• Primary Completion: 2011-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. Consolidation with Y90 Ibritumomab Tiuxetan	Y90 Ibritumomab Tiuxetan	1. Consolidation with Y90 Ibritumomab Tiuxetan

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (11)

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Santa Cruz de Tenerife, Spain

Hospital Virgen de la Salud de Toledo; 🇪🇸 Toledo, Spain

Clínica Ruber Internacional; 🇪🇸 Madrid, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Malaga, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Spain

Clinia Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Hospital Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Instituto Oncológico San Sebastián; 🇪🇸 Donostia, San Sebastián, Spain