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 because the information has not been verified recently.
Verified July 2008 by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
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
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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: | Endpoint Classification: Efficacy Study 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:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Ibritumomab tiuxetan
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective clinical response rate (complete + partial). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Response conversion rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence of complete molecular responses [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Event-free survival. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Time to salvage therapy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Lymphoma-free or specific cause-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Toxicity profile and safety of the consolidation [ Time Frame: 60 months ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722930
Contacts
| Contact: Mariano Provencio, MD | +34-91-344-57-60 | mprovenciop@yahoo.es |
| Contact: Sandra Cerdeira, Secretary | 34 91 3445131 | secretariatecnica@grupolinfomas.es |
Locations
| Spain | |
| 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
Investigators
| Principal Investigator: | Mariano Provencio, MD | Clínica Puerta de Hierro |
More Information
No publications provided
| 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 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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 Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013