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 currently recruiting participants.
Verified November 2013 by PETHEMA Foundation
Sponsor:
Collaborators:
GELCAB
GLIMCE
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
GRUPO ARAGONÉS
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00662948
First received: April 8, 2008
Last updated: November 19, 2013
Last verified: November 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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®)

Resource links provided by NLM:


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: December 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Active Comparator: B
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
Hospital de Alcorcón Recruiting
Alcorcón, Spain
Contact: Peñalver Francisco, Dr         
Principal Investigator: Peñalver Francisco, Dr         
Hospital germans Trias i Pujol Recruiting
Badalona, Spain
Contact: Sancho Juan Manuel, Dr         
Principal Investigator: Sancho Juan Manuel, Dr         
Hospital Clínic Recruiting
Barcelona, Spain
Contact: López Guillermo Armando, Dr         
Principal Investigator: López Guillermo Armando, Dr         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Salar Antonio, Dr         
Principal Investigator: Salar Antonio, Dr         
Hospital de la santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Delgado Julio, Dr         
Principal Investigator: Delgado Julio, Dr         
Hospital Juan Canalejo Recruiting
La Coruña, Spain
Contact: Deben Guillermo, Dr         
Principal Investigator: Deben Guillermo, Dr         
Hospital La Paz Recruiting
Madrid, Spain
Contact: Canales Miguel Ángel, Dr         
Principal Investigator: Canales Miguel Angel, Dr         
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Contact: Montalban Carlos, Dr         
Principal Investigator: Montalban Carlos, Dr         
Hospital Doce de Octubre Recruiting
Madrid, Spain
Contact: de la Serna Javier, Dr         
Principal Investigator: de la Serna Javier, Dr         
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Martínez Rafael, Dr         
MD Anderson Recruiting
Madrid, Spain
Contact: Tomás José Francisco, Dr         
Principal Investigator: Tomás José Francisco, Dr         
Hospital Virgen de la Arrixaca Recruiting
Murcia, Spain
Contact: Moraleda José María, Dr         
Principal Investigator: Moraleda José María, Dr         
Hospital son Dureta Recruiting
Palma de Mallorca, Spain
Contact: Besalduch Joan, Dr         
Principal Investigator: Besalduch Joan, Dr         
Hospital Clínico Recruiting
Salamanca, Spain
Contact: Caballero Dolores, Dr         
Principal Investigator: Caballero Dolores, Dr         
Hospital de Donostia Recruiting
San Sebastián, Spain
Contact: Marín Julián, Dr         
Principal Investigator: Marín Julián, Dr         
Hoaspital Marqués de Valdecilla Recruiting
Santander, Spain
Contact: Conde Eulogio, Dr         
Principal Investigator: Conde Eulogio, Dr         
Hospital Clínico Universitario Recruiting
Santiago de Compostela, Spain
Contact: Bello . José Luis, Dr         
Principal Investigator: Bello . José Luis, Dr         
Hospital General Recruiting
V alencia, Spain
Contact: Carbonell Félix, Dr         
Principal Investigator: Carbonell Félix, Dr         
Hospital Clínico Recruiting
Valencia, Spain
Contact: Terol María José, Dr         
Principal Investigator: Terol María José, Dr         
Hospital La Fe Recruiting
Valencia, Spain
Contact: Jarque Isidro, Dr         
Principal Investigator: Jarque Isidro, Dr         
Hospital Dr Pesset Recruiting
Valencia, Spain
Contact: Ferrer Secundino, Dr         
Principal Investigator: Ferrer Secundino, Dr         
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 of Barcelona
Study Chair: Tomas Jose Francisco, Dr MD Anderson- Madrid
  More Information

Additional Information:
No publications provided

Responsible Party: Pethema
ClinicalTrials.gov Identifier: NCT00662948     History of Changes
Other Study ID Numbers: ZAR2007
Study First Received: April 8, 2008
Last Updated: November 19, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Folicular Lymphoma
Consolidation
Maintenance

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014