Status:
COMPLETED
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
GELCAB
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Conditions:
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to: A: Consolidation with one dose of 90Y Ibritumo...
Detailed Description
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction...
Eligibility Criteria
Inclusion
- Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
- Patients no treated previously.
- Ann Arbor Stage II, III o IV.
- Symptoms or signes wich indicate necesary treatment (GELF criteria):
- Ganglionar or extraganglionar mass
- B Symptoms
- LDH or B2-microglobuline increased
- 3 ganglionar territory afected (\> 3 cm)
- Esplenomegalia
- Compresive syndrome
- Pleural/peritoneal effusion
- Secondary medular insufiency due to infiltration
- Age\> 18 years and \<75 years.
- ECOG \< 2
- Adecuate hematological function: Hemoglobin \> 8,0 g/dl (5,0 mmol/L); RAN \>1,5 x 109/L; platelets \> 100 x 109/L
- No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after
- Informed consent
Exclusion
- Transformation in high grade lymphoma
- FL grade 3b.
- Skin or gastro-intestinal primary lymphoma
- History of CNS diseases ( or CNS lymphoma)
- Previous treatment
- Regulary treatment with corticosteroids (permited \< 20 mg/day prednisone or equivalent).
- Previous cancer diseases
- Major surgery in 28 days before inclusion in study.
- Creatinine \> 2,0 mg/dl (197 mmol/L)
- Bilirubin \> 2,0 mg/dl (34 mmol/L), AST (SGOT) \> 3 x upper normal limit.
- HIV infection or active infection VHB o VHC \< 4 weeks before inclusion.
- Other complicated diseases
- Criteria investigador:
- Life expectancy \< 6 months.
- Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients.
- Treatment in other experimental study in previous 30 days
- Any medical o psicologycal condition that can modify the capacity to give the consent
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2017
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00662948
Start Date
December 1 2008
End Date
October 30 2017
Last Update
April 28 2020
Active Locations (21)
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1
Hospital Juan Canalejo
A Coruña, Spain
2
Hospital de Alcorcón
Alcorcón, Spain
3
Hospital germans Trias i Pujol
Badalona, Spain
4
Hospital Clínic
Barcelona, Spain