Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma (GOTEL-FL1LC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
ClinicalTrials.gov Identifier:
NCT00722930
First received: July 25, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose
To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy

Condition Intervention Phase
Follicular Lymphoma
Drug: Y90 Ibritumomab Tiuxetan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy

Resource links provided by NLM:


Further study details as provided by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas:

Primary Outcome Measures:
  • CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease [ Time Frame: 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter ]

Secondary Outcome Measures:
  • Objective clinical response rate (complete + partial). [ Time Frame: 3 months ]
  • Response conversion rate [ Time Frame: 3 months ]
  • Incidence of complete molecular responses [ Time Frame: 3 months ]
  • Response duration [ Time Frame: 36 months ]
  • Event-free survival. [ Time Frame: 36 months ]
  • Progression-free survival [ Time Frame: 36 months ]
  • Time to salvage therapy [ Time Frame: 36 months ]
  • Lymphoma-free or specific cause-free survival [ Time Frame: 36 months ]
  • Overall survival [ Time Frame: 60 months ]
  • Toxicity profile and safety of the consolidation [ Time Frame: 60 months ]

Estimated Enrollment: 38
Study Start Date: April 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Consolidation with Y90 Ibritumomab Tiuxetan
1. Consolidation with Y90 Ibritumomab Tiuxetan
Drug: Y90 Ibritumomab Tiuxetan
Consolidation with Y90 Ibritumomab Tiuxetan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure.
  • Patients older than 18.
  • Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.
  • High-risk patients according to FLIPI before initiation of induction chemotherapy.
  • Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.
  • Complete or partial response to the induction scheme.
  • ECOG scale performance status 0 - 2.
  • Life expectancy greater than 3 months.
  • In women of childbearing age, use of a reliable contraceptive method.
  • A suitable bone marrow reserve:

    • Lower than 25% Bone marrow infiltration by lymphoma.
    • Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
    • Suitable hepatic, renal and cardiac function:

      • creatinine <2,5 x UNL (upper normality limit).
      • bilirubin or ALT/AST < 2,5 x UNL

Exclusion Criteria:

  • Patients with no objective clinical response to induction chemotherapy.
  • > 25% bone marrow infiltration following induction chemotherapy.
  • Platelets < 100,000 before radioimmunotherapy.
  • Severe and/or uncontrolled concomitant disease:
  • Hepatic, renal, cardiovascular, neurological or metabolic disease.
  • Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.
  • Positive regarding HBV, HCV, HIV.
  • Active acute or chronic infection.
  • Social, psychic or geographic disability to satisfy any of the treatment schemes.
  • Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.
  • Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).
  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: NCT00722930

Locations
Spain
Hospital Virgen de la Victoria
Málaga, Malaga, Spain
Instituto Oncológico San Sebastián
Donostia, San Sebastián, Spain
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Virgen de las Nieves
Granada, Spain
Clinia Puerta de Hierro
Madrid, Spain
Clínica Ruber Internacional
Madrid, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Spain
Hospital Universitario Virgen Macarena
Sevilla, Spain
Hospital Virgen de la Salud de Toledo
Toledo, Spain
Hospital Universitario La Fe
Valencia, Spain
Sponsors and Collaborators
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Investigators
Principal Investigator: Mariano Provencio, MD Clínica Puerta de Hierro
  More Information

Responsible Party: Dr. Mariano Provencio, Clínica Puerta de Hierro, Servicio de Oncología Médica
ClinicalTrials.gov Identifier: NCT00722930     History of Changes
Other Study ID Numbers: GOTEL-FL1LC-0701  Eudra-CT 2007-003091-19 
Study First Received: July 25, 2008
Last Updated: July 25, 2008

Keywords provided by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas:
Follicular Lymphoma
High-risk FLIPI
R-CHOP
GOTEL
Partial
Complete
Response
Induction
Chemotherapy

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 23, 2017