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ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
This study is not yet open for participant recruitment.
Verified by PETHEMA Foundation, April 2008
Sponsors and Collaborators: PETHEMA Foundation
GELCAB
GLIMCE
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
GRUPO ARAGONÉS
Information provided by: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00662948
  Purpose

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


Condition Intervention Phase
Lymphoma
Drug: Rituximab
Drug: Ibritumomab tiuxetan
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab Ibritumomab tiuxetan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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®)

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Saffetty of two arms [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Global survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Event free survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Response rate in two arms [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
Drug: Ibritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
B: Active Comparator
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Drug: Rituximab
375 mg/m2 every 8 weeks during 24 months

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 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662948

Contacts
Contact: Canales Miguel, Dr 93 227 54 00
Contact: Lopez-Guillermo Armando, Dr 93 227 54 00

Locations
Spain
MD Anderson
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital de Alcorcón
Alcorcón, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Clínic
Barcelona, Spain
Hospital de la santa Creu i Sant Pau
Barcelona, Spain
Hospital germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital La Fe
Valencia, Spain
Hospital Clínico
Valencia, Spain
Hospital General
V alencia, Spain
Hoaspital Marqués de Valdecilla
Santander, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital Clínico Universitario
Santiago de Compostela, Spain
Hospital Dr Pesset
Valencia, Spain
Hospital Clínico
Salamanca, Spain
Hospital de Donostia
San Sebastián, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital son Dureta
Palma de Mallorca, Spain
Sponsors and Collaborators
PETHEMA Foundation
GELCAB
GLIMCE
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
GRUPO ARAGONÉS
Investigators
Study Chair: Canales Miguel, Dr Hospital La Paz
Study Chair: Lopez-Guillermo Armando, Dr Hospital Clinic Barcelona
Study Chair: Tomas Jose Francisco, Dr MD Anderson- Madrid
  More Information

Pethema Foundation web  This link exits the ClinicalTrials.gov site
spanish hematology association  This link exits the ClinicalTrials.gov site

Responsible Party: Pethema ( Pethema )
Study ID Numbers: ZAR2007
Study First Received: April 8, 2008
Last Updated: April 17, 2008
ClinicalTrials.gov Identifier: NCT00662948  
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Folicular Lymphoma
Consolidation
Maintenance

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009