ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

• Status: Completed
• Trial end date: 2017-10-30
• Target enrollment: 0
• Participant gender: All

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 Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Collaborators: GELCAB; Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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