Trial Title:
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
NCT ID:
NCT00722930
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Antibodies, Monoclonal
Conditions: Keywords:
Follicular Lymphoma
High-risk FLIPI
R-CHOP
GOTEL
Partial
Complete
Response
Induction
Chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Y90 Ibritumomab Tiuxetan
Description:
Consolidation with Y90 Ibritumomab Tiuxetan
Arm group label:
1. Consolidation with Y90 Ibritumomab Tiuxetan
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:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Virgen de la Victoria
Address:
City:
Málaga
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Instituto Oncológico San Sebastián
Address:
City:
Donostia
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario de Canarias
Address:
City:
La Laguna
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Sant Joan de Reus
Address:
City:
Reus
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Virgen de las Nieves
Address:
City:
Granada
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Clinia Puerta de Hierro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Mariano Provencio, MD
Email:
Principal Investigator
Facility:
Name:
Clínica Ruber Internacional
Address:
City:
Madrid
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Complejo Hospitalario de Pontevedra
Address:
City:
Pontevedra
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Virgen de la Salud de Toledo
Address:
City:
Toledo
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario La Fe
Address:
City:
Valencia
Country:
Spain
Status:
Active, not recruiting
Start date:
April 2008
Completion date:
April 2013
Lead sponsor:
Agency:
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Agency class:
Other
Source:
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00722930
