Follicular Lymphoma
Conditions
Keywords
Follicular Lymphoma, High-risk FLIPI, R-CHOP, GOTEL, Partial, Complete, Response, Induction, Chemotherapy
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
Interventions
DRUGY90 Ibritumomab Tiuxetan
Consolidation with Y90 Ibritumomab Tiuxetan
Sponsors
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Response conversion rate | 3 months |
| Incidence of complete molecular responses | 3 months |
| Response duration | 36 months |
| Event-free survival. | 36 months |
| Objective clinical response rate (complete + partial). | 3 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 |
| Progression-free survival | 36 months |
Countries
Spain
Contacts
Primary ContactMariano Provencio, MD
Backup ContactSandra Cerdeira, Secretary
Outcome results
None listed