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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®)

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Rituximab
Ibritumomab tiuxetan
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Folicular Lymphoma, Consolidation, Maintenance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Alcorcón
  • Hospital germans Trias i Pujol
  • Hospital Clínic
  • Hospital de la santa Creu i Sant Pau
  • Hospital del Mar
  • Hospital Juan Canalejo
  • Hospital Clinico San Carlos
  • Hospital Doce de Octubre
  • Hospital La Paz
  • Hospital Ramón y Cajal
  • MD Anderson
  • Hospital Virgen de la Arrixaca
  • Hospital son Dureta
  • Hospital Clínico
  • Hospital de Donostia
  • Hoaspital Marqués de Valdecilla
  • Hospital Clínico Universitario
  • Hospital General
  • Hospital Clínico
  • Hospital Dr Pesset
  • Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg

Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Saffetty of two arms
Quality of life
Global survival
Event free survival
Response rate in two arms

Full Information

First Posted
April 8, 2008
Last Updated
April 27, 2020
Sponsor
PETHEMA Foundation
Collaborators
GELCAB, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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1. Study Identification

Unique Protocol Identification Number
NCT00662948
Brief Title
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2008 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation
Collaborators
GELCAB, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Folicular Lymphoma, Consolidation, Maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
Arm Title
B
Arm Type
Active Comparator
Arm Description
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 every 8 weeks during 24 months
Intervention Type
Drug
Intervention Name(s)
Ibritumomab tiuxetan
Intervention Description
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Saffetty of two arms
Time Frame
2 years
Title
Quality of life
Time Frame
7 years
Title
Global survival
Time Frame
7 years
Title
Event free survival
Time Frame
7 years
Title
Response rate in two arms
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canales Miguel, Dr
Organizational Affiliation
Hospital La Paz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lopez-Guillermo Armando, Dr
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tomas Jose Francisco, Dr
Organizational Affiliation
MD Anderson- Madrid
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Alcorcón
City
Alcorcón
Country
Spain
Facility Name
Hospital germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Facility Name
Hospital de la santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
MD Anderson
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Clínico
City
Salamanca
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastián
Country
Spain
Facility Name
Hoaspital Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital General
City
V Alencia
Country
Spain
Facility Name
Hospital Clínico
City
Valencia
Country
Spain
Facility Name
Hospital Dr Pesset
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34459702
Citation
Lopez-Guillermo A, Canales MA, Dlouhy I, Mercadal S, Briones J, Martin Garcia-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, Lopez A, Panizo C, Muntanola A, Montalban C, Conde E, Hernandez MT, Soler A, Garcia Marco JA, Deben G, Marin J, Tomas JF; PETHEMA/GELTAMO/GELCAB Spanish Intergroup. A randomized phase II study comparing consolidation with a single dose of 90Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results. Leuk Lymphoma. 2022 Jan;63(1):93-100. doi: 10.1080/10428194.2021.1971216. Epub 2021 Aug 30.
Results Reference
derived
Links:
URL
http://aehh.org
Description
spanish hematology association

Learn more about this trial

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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