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Trial record 60 of 1147 for:    "Follicular lymphoma"

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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00722930
Recruitment Status : Unknown
Verified July 2008 by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas.
Recruitment status was:  Recruiting
First Posted : July 28, 2008
Last Update Posted : July 28, 2008
Information provided by:
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Brief Summary:
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 or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Y90 Ibritumomab Tiuxetan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1. Consolidation with Y90 Ibritumomab Tiuxetan
1. Consolidation with Y90 Ibritumomab Tiuxetan
Drug: Y90 Ibritumomab Tiuxetan
Consolidation with Y90 Ibritumomab Tiuxetan

Primary Outcome Measures :
  1. 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 :
  1. Objective clinical response rate (complete + partial). [ Time Frame: 3 months ]
  2. Response conversion rate [ Time Frame: 3 months ]
  3. Incidence of complete molecular responses [ Time Frame: 3 months ]
  4. Response duration [ Time Frame: 36 months ]
  5. Event-free survival. [ Time Frame: 36 months ]
  6. Progression-free survival [ Time Frame: 36 months ]
  7. Time to salvage therapy [ Time Frame: 36 months ]
  8. Lymphoma-free or specific cause-free survival [ Time Frame: 36 months ]
  9. Overall survival [ Time Frame: 60 months ]
  10. Toxicity profile and safety of the consolidation [ Time Frame: 60 months ]

Information from the National Library of Medicine

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00722930

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Contact: Mariano Provencio, MD +34-91-344-57-60
Contact: Sandra Cerdeira, Secretary 34 91 3445131

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Hospital Virgen de la Victoria Active, not recruiting
Málaga, Malaga, Spain
Instituto Oncológico San Sebastián Active, not recruiting
Donostia, San Sebastián, Spain
Hospital Universitario de Canarias Active, not recruiting
La Laguna, Santa Cruz de Tenerife, Spain
Hospital Sant Joan de Reus Active, not recruiting
Reus, Tarragona, Spain
Hospital Virgen de las Nieves Active, not recruiting
Granada, Spain
Clinia Puerta de Hierro Recruiting
Madrid, Spain
Principal Investigator: Mariano Provencio, MD         
Clínica Ruber Internacional Active, not recruiting
Madrid, Spain
Complejo Hospitalario de Pontevedra Active, not recruiting
Pontevedra, Spain
Hospital Universitario Virgen Macarena Active, not recruiting
Sevilla, Spain
Hospital Virgen de la Salud de Toledo Active, not recruiting
Toledo, Spain
Hospital Universitario La Fe Active, not recruiting
Valencia, Spain
Sponsors and Collaborators
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
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Principal Investigator: Mariano Provencio, MD Clínica Puerta de Hierro

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Responsible Party: Dr. Mariano Provencio, Clínica Puerta de Hierro, Servicio de Oncología Médica Identifier: NCT00722930     History of Changes
Other Study ID Numbers: GOTEL-FL1LC-0701
Eudra-CT 2007-003091-19
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008
Keywords provided by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas:
Follicular Lymphoma
High-risk FLIPI
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs