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. (see Contacts and Locations)
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

April 8, 2008
November 19, 2013
December 2008
May 2016   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662948 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
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®)

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: Rituximab
    375 mg/m2 every 8 weeks during 24 months
  • Drug: Ibritumomab tiuxetan
    One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
  • Experimental: A
    Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
    Intervention: Drug: Ibritumomab tiuxetan
  • Active Comparator: B
    Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
    Intervention: Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Canales Miguel, Dr 93 227 54 00
Contact: Lopez-Guillermo Armando, Dr 93 227 54 00
Spain
 
NCT00662948
ZAR2007
Yes
Pethema
PETHEMA Foundation
  • GELCAB
  • GLIMCE
  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
  • GRUPO ARAGONÉS
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
PETHEMA Foundation
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP