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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 has suspended participant recruitment.
(No inclusion)
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: October 27, 2014
Last verified: October 2014
  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: October 2014
Primary Completion Date: October 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662948

Locations
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 Ramón y Cajal
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Clinico San Carlos
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, 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 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: October 27, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Folicular Lymphoma
Consolidation
Maintenance

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

ClinicalTrials.gov processed this record on November 25, 2014