ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

April 27, 2020 updated by: PETHEMA Foundation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alcorcón, Spain
        • Hospital de Alcorcón
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clínic
      • La Coruña, Spain
        • Hospital Juan Canalejo
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • MD Anderson
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Palma de Mallorca, Spain
        • Hospital Son Dureta
      • Salamanca, Spain
        • Hospital Clinico
      • San Sebastián, Spain
        • Hospital de Donostia
      • Santander, Spain
        • Hoaspital Marqués de Valdecilla
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario
      • V Alencia, Spain
        • Hospital General
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital Dr Pesset
      • Valencia, Spain
        • Hospital Clinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Saffetty of two arms
Time Frame: 2 years
2 years
Quality of life
Time Frame: 7 years
7 years
Global survival
Time Frame: 7 years
7 years
Event free survival
Time Frame: 7 years
7 years
Response rate in two arms
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
GELCAB

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAR2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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