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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
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
Follicular Lymphoma, High-risk FLIPI, R-CHOP, GOTEL, Partial, Complete, Response, Induction, Chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Y90 Ibritumomab Tiuxetan
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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).
- 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).
Locations
Hospital Virgen de la Victoria
Málaga, Malaga, Spain
Instituto Oncológico San Sebastián
Status: Active, not recruiting
Donostia, San Sebastián, Spain
Hospital Universitario de Canarias
Status: Active, not recruiting
La Laguna, Santa Cruz de Tenerife, Spain
Hospital Sant Joan de Reus
Status: Active, not recruiting
Reus, Tarragona, Spain
Hospital Virgen de las Nieves
Status: Active, not recruiting
Granada, Spain
Clinia Puerta de Hierro
Status: Active, not recruiting
Madrid, Spain
Clínica Ruber Internacional
Status: Recruiting
Madrid, Spain
Complejo Hospitalario de Pontevedra
Status: Active, not recruiting
Pontevedra, Spain
Hospital Universitario Virgen Macarena
Status: Active, not recruiting
Sevilla, Spain
Hospital Virgen de la Salud de Toledo
Status: Active, not recruiting
Toledo, Spain
Hospital Universitario La Fe
Status: Active, not recruiting
Valencia, Spain
Status: Active, not recruiting
Start Date
April 2008
Completion Date
April 2013
Sponsors
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Source
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page