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
GOTEL-FL1LC
2 other identifiers
interventional
38
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2008
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 28, 2008
July 1, 2008
3 years
July 25, 2008
July 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (1)
1. Consolidation with Y90 Ibritumomab Tiuxetan
EXPERIMENTAL1\. Consolidation with Y90 Ibritumomab Tiuxetan
Interventions
Consolidation with Y90 Ibritumomab Tiuxetan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hospital Virgen de las Nieves
Granada, Granada, Spain
Clinia Puerta de Hierro
Madrid, Madrid, Spain
Clínica Ruber Internacional
Madrid, Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Malaga, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Pontevedra, Spain
Instituto Oncológico San Sebastián
Donostia / San Sebastian, San Sebastián, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Virgen de la Salud de Toledo
Toledo, Toledo, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariano Provencio, MD
Clínica Puerta de Hierro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 28, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2013
Last Updated
July 28, 2008
Record last verified: 2008-07