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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®)

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ClinicalTrials.gov Identifier: NCT00662948
Recruitment Status : Suspended (No inclusion)
First Posted : April 21, 2008
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
GELCAB
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by (Responsible Party):
PETHEMA Foundation

Brief 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


Condition or disease Intervention/treatment Phase
Lymphoma Drug: Rituximab Drug: Ibritumomab tiuxetan Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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®)
Study Start Date : December 2008
Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Saffetty of two arms [ Time Frame: 2 years ]
  2. Quality of life [ Time Frame: 7 years ]
  3. Global survival [ Time Frame: 7 years ]
  4. Event free survival [ Time Frame: 7 years ]
  5. Response rate in two arms [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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, Spain
Sponsors and Collaborators
PETHEMA Foundation
GELCAB
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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

Additional Information:
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00662948     History of Changes
Other Study ID Numbers: ZAR2007
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: May 2016

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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents