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

PETHEMA Foundation

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Treatments

Drug: Ibritumomab tiuxetan

Drug: Rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00662948

ZAR2007

Details and patient eligibility

About

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

Full 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 with chemotherapy and rituximab in folicular lymphoma patients no treated previously.

The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity

Enrollment

149 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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