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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2007-003198 - 22 |
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To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BEAM preceded by Ybritumomab Tiuxetan (Zevalin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) | Drug | Day -21: rituximab. 250 mg/m2 iv Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi). Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease clinical response to treatment - complete response rate. | Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen. | 36 months | |
| Overall response rate (complete + partial response) | 36 month | |
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Inclusion Criteria:
Give their written informed consent.
Abide by at least one of the following conditions:
Stable disease at the time of transplantation.
Age ≥ 18 but ≤ 70.
Life expectancy of greater than three months.
Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Briones, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Dolores Caballero, MD | Hospital Clínico Universitario de Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Alicante | Alicante | Alicante | Spain | |||
| H. de la Santa Creu i Sant Pau |
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|
|
| Progression-free-survival |
| 36 month |
| Overall survival | 96 months |
| Post-transplantation haematological and immunological reconstitution | Until post-transplantation day +100 |
| Barcelona |
| Barcelona |
| Spain |
| Instituto Catalán de Oncología, | Barcelona | Barcelona | Spain |
| H.Universitario de Canarias | Santa Cruz de Tenerife | Canary Islands | Spain |
| H.U. Marqués de Valdecilla | Santander | Cantabria | Spain |
| H. Reina Sofía | Córdoba | Córdoba | Spain |
| Clínica Puerta de Hierro, | Madrid | Madrid | Spain |
| H.U. 12 de Octubre, | Madrid | Madrid | Spain |
| H.U. Gregorio Marañón, | Madrid | Madrid | Spain |
| H.U. La Paz | Madrid | Madrid | Spain |
| H.U. La Princesa | Madrid | Madrid | Spain |
| M.D. Anderson Internacional | Madrid | Madrid | Spain |
| H. Morales Messeguer | Murcia | Murcia | Spain |
| H.U. Virgen de la Arrixaca | Murcia | Murcia | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | Spain |
| H.U. Central de Asturias, Oviedo | Oviedo | Principality of Asturias | Spain |
| H. Clínico Universitario de Salamanca | Salamanca | Salamanca | Spain |
| H.U. La Fe | Valencia | Valencia | Spain |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| 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 |
| D000069283 | Rituximab |
| D002330 | Carmustine |
| D005047 | Etoposide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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