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| ID | Type | Description | Link |
|---|---|---|---|
| EuDRACT nº:2007-003302-10 |
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To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibritumomab Tiuxetan (Zevalin) | Drug | Conditioning Regimen
Chemotherapy:
Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety (toxicity, transplantation- and graft-related mortality) | 36 months | |
| response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007). | 36 months | |
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Inclusion Criteria:
Written informed consent
Histologically confirmed B-cell lymphoma of the following subtypes:
High-risk B-cell CD20+ lymphoma defined by
Stable disease at the time of transplantation
Age between 18 and 65
Performance status (ECOG) ≤ 2
Normal and suitable pulmonary function (DLCO ≥ 30%)
Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%
Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dolores Caballero, MD | Hospital Clínico Universitario de Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Santa Creu i Sant Pau. | Barcelona | Barcelona. | Spain | |||
| H. U. Marqués de Valdecilla. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27771496 | Derived | Cabrero M, Martin A, Briones J, Gayoso J, Jarque I, Lopez J, Grande C, Heras I, Arranz R, Bernal T, Perez-Lopez E, Lopez-Godino O, Conde E, Caballero D. Phase II Study of Yttrium-90-Ibritumomab Tiuxetan as Part of Reduced-Intensity Conditioning (with Melphalan, Fludarabine +/- Thiotepa) for Allogeneic Transplantation in Relapsed or Refractory Aggressive B Cell Lymphoma: A GELTAMO Trial. Biol Blood Marrow Transplant. 2017 Jan;23(1):53-59. doi: 10.1016/j.bbmt.2016.10.003. Epub 2016 Oct 19. |
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|
|
| overall survival |
| 36 months |
| relapse rate | 36 months |
| acute and chronic Graft-versus-Host Disease | 36 months |
| haematological and immunological reconstitution, and chimerism. | Post transplantation. Once weekly until day +100 and every 2 weeks from day +100. |
| the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival | 36 months |
| Santander |
| Cantabria |
| Spain |
| H.U. 12 de Octubre | Madrid | Madrid | Spain |
| H.U. Gregorio Marañón | Madrid | Madrid | Spain |
| H.U. La Princesa | Madrid | Madrid | Spain |
| H.U. Ramón y Cajal. | Madrid | Madrid | Spain |
| H. Morales Meseguer. | Murcia | Murcia | Spain |
| H. Virgen de la Arrixaca | Murcia | Murcia | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | Spain |
| H. Central de Asturias | Oviedo | Oviedo | Spain |
| H. Clinico de Salamanca | Salamanca | Salamanca | Spain |
| H. Clínico Valencia | Valencia | Valencia | Spain |
| H. La Fe | Valencia | Valencia | Spain |
| H.U. Miguel Servet | Zaragoza | Zaragoza. | 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 |
| 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 |
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