View Clinical Trial (Medical Research Study)

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 - NCT00722930-Donostia - 008(Clinical Trial 233665)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials
Signup
City:  Donostia
Country:  
Spain
Conditions: Follicular Lymphoma
Purpose: 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
Study summary:
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).
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: February 16, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.