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

Lymphoma Clinical Trial

Official title:

Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662948
• Other study ID #: ZAR2007
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: October 30, 2017

Study information

• Verified date: April 2020
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: October 30, 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Rituximab
375 mg/m2 every 8 weeks during 24 months
• Ibritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg

Locations

Country	Name	City	State
Spain	Hospital de Alcorcón	Alcorcón
Spain	Hospital germans Trias i Pujol	Badalona
Spain	Hospital Clínic	Barcelona
Spain	Hospital de la santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Juan Canalejo	La Coruña
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	MD Anderson	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital son Dureta	Palma de Mallorca
Spain	Hospital Clínico	Salamanca
Spain	Hospital de Donostia	San Sebastián
Spain	Hoaspital Marqués de Valdecilla	Santander
Spain	Hospital Clínico Universitario	Santiago de Compostela
Spain	Hospital General	V Alencia
Spain	Hospital Clínico	Valencia
Spain	Hospital Dr Pesset	Valencia
Spain	Hospital La Fe	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
PETHEMA Foundation	GELCAB, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		2 years
Secondary	Saffetty of two arms		2 years
Secondary	Quality of life		7 years
Secondary	Global survival		7 years
Secondary	Event free survival		7 years
Secondary	Response rate in two arms		3 years

External Links

•   spanish hematology association