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)

Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy

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

Study Overview

• Status: Unknown
• Conditions: Follicular Lymphoma
• Intervention / Treatment: Drug: Y90 Ibritumomab Tiuxetan

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mariano Provencio, MD; Phone Number: +34-91-344-57-60; Email: mprovenciop@yahoo.es
• Study Contact Backup: Name: Sandra Cerdeira, Secretary; Phone Number: 34 91 3445131; Email: secretariatecnica@grupolinfomas.es

Study Locations

• Spain
  • Granada, Spain
    • Active, not recruiting
    • Hospital Virgen de las Nieves
  • Madrid, Spain
    • Recruiting
    • Clinia Puerta de Hierro
  • Madrid, Spain
    • Active, not recruiting
    • Clinica Ruber Internacional
  • Pontevedra, Spain
    • Active, not recruiting
    • Complejo Hospitalario de Pontevedra
  • Sevilla, Spain
    • Active, not recruiting
    • Hospital Universitario Virgen Macarena
  • Toledo, Spain
    • Active, not recruiting
    • Hospital Virgen de la Salud de Toledo
  • Valencia, Spain
    • Active, not recruiting
    • Hospital Universitario La Fe
  • Malaga
    • Málaga, Malaga, Spain
      • Active, not recruiting
      • Hospital Virgen de la Victoria
  • San Sebastián
    • Donostia, San Sebastián, Spain
      • Active, not recruiting
      • Instituto Oncológico San Sebastián
  • Santa Cruz de Tenerife
    • La Laguna, Santa Cruz de Tenerife, Spain
      • Active, not recruiting
      • Hospital Universitario de Canarias
  • Tarragona
    • Reus, Tarragona, Spain
      • Active, not recruiting
      • Hospital Sant Joan de Reus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1. Consolidation with Y90 Ibritumomab Tiuxetan	Drug: Y90 Ibritumomab Tiuxetan; Consolidation with Y90 Ibritumomab Tiuxetan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
• Investigators: Principal Investigator: Mariano Provencio, MD, Clínica Puerta de Hierro

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ANTICIPATED): April 1, 2011
• Study Completion (ANTICIPATED): April 1, 2013

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (ESTIMATE): July 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2008
• Last Update Submitted That Met QC Criteria: July 25, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Follicular Lymphoma; Chemotherapy; Response; R-CHOP; Induction; Partial; High-risk FLIPI; GOTEL; Complete
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: GOTEL-FL1LC-0701; Eudra-CT 2007-003091-19