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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra-CT 2007-003091-19 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Consolidation with Y90 Ibritumomab Tiuxetan | Experimental | 1. Consolidation with Y90 Ibritumomab Tiuxetan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y90 Ibritumomab Tiuxetan | Drug | Consolidation with Y90 Ibritumomab Tiuxetan |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective clinical response rate (complete + partial). | 3 months | |
| Response conversion rate | 3 months | |
| Incidence of complete molecular responses |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariano Provencio, MD | Contact | +34-91-344-57-60 | mprovenciop@yahoo.es | |
| Sandra Cerdeira, Secretary | Contact | 34 91 3445131 | secretariatecnica@grupolinfomas.es |
| Name | Affiliation | Role |
|---|---|---|
| Mariano Provencio, MD | Clínica Puerta de Hierro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de las Nieves | Active, not recruiting | Granada | Granada | Spain | ||
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| 3 months |
| Response duration | 36 months |
| Event-free survival. | 36 months |
| Progression-free survival | 36 months |
| Time to salvage therapy | 36 months |
| Lymphoma-free or specific cause-free survival | 36 months |
| Overall survival | 60 months |
| Toxicity profile and safety of the consolidation | 60 months |
| Clinia Puerta de Hierro |
| Recruiting |
| Madrid |
| Madrid |
| Spain |
|
| Clínica Ruber Internacional | Active, not recruiting | Madrid | Madrid | Spain |
| Hospital Virgen de la Victoria | Active, not recruiting | Málaga | Malaga | Spain |
| Complejo Hospitalario de Pontevedra | Active, not recruiting | Pontevedra | Pontevedra | Spain |
| Instituto Oncológico San Sebastián | Active, not recruiting | Donostia / San Sebastian | San Sebastián | Spain |
| Hospital Universitario de Canarias | Active, not recruiting | San Cristóbal de La Laguna | Santa Cruz de Tenerife | Spain |
| Hospital Universitario Virgen Macarena | Active, not recruiting | Seville | Sevilla | Spain |
| Hospital Sant Joan de Reus | Active, not recruiting | Reus | Tarragona | Spain |
| Hospital Virgen de la Salud de Toledo | Active, not recruiting | Toledo | Toledo | Spain |
| Hospital Universitario La Fe | Active, not recruiting | Valencia | Valencia | Spain |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
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