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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-005254-68 |
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The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.
In addition to the above:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-MEGACHOP | Drug |
R-IFE: 2 cycles every 21 days: IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3. ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3). |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH | 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the overall survival after three years. Further secondary outcomes as described in study summary. | 5 years follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Fuster, MD | Son Dureta Hospital | Principal Investigator |
| Carlos Grande, MD | 12 Octubre Hospital | Principal Investigator |
| José Luís Bello, MD | Santiago Hospital | Principal Investigator |
| Maria José Ramirez, MD | Jerez Hospital | Principal Investigator |
| Carlos Panizo, MD | Navarra Clinic | Principal Investigator |
| Elena Pérez, MD | Morales i Meseguer Hospital | Principal Investigator |
| Jorge Gayoso, MD | Gregorio Marañon Hospital | Principal Investigator |
| Reyes Arranz, MD | Princesa Hospital | Principal Investigator |
| Eulogio Conde, MD | Marques de Valdecilla Hospital | Principal Investigator |
| Eva González, MD | Duran i Reynals Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO- Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Hospital Universitario Marques de Valdecilla |
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| Principal Investigator |
| Miguel Canales, MD | La Paz Hospital | Principal Investigator |
| Joan Bargay, MD | Son Llatzer Hospital | Principal Investigator |
| Miguel T. Hernández, MD | Canarias University Hospital | Principal Investigator |
| Antonio Alcala, MD | Jaen Hospital | Principal Investigator |
| Luis Palomera, MD | Lozano Blesa Clinic | Principal Investigator |
| José Queizán, MD | Segovia Hospital | Principal Investigator |
| María José Peñarrubia, MD | Río Hortega Hospital | Principal Investigator |
| Alejandro Martín, MD | Virgen de la Concha Hospital | Principal Investigator |
| Sílvia Fernández, MD | León Hospital | Principal Investigator |
| Santander |
| Cantabria |
| 39008 |
| Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Clínico Univ. de Santiago | Santiago de Compostela | Galicia | 15706 | Spain |
| Complejo Hospitalario de Jaén | Jaén | Jaén | 23006 | Spain |
| Hospital Universitario La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Universitario Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Univ. Son Dureta | Palma de Mallorca | Mallorca | 07014 | Spain |
| Hospital Son Llàtzer | Palma de Mallorca | Mallorca | 07198 | Spain |
| Hospital Univ. Morales Meseguer | Murcia | Murcia | 30008 | Spain |
| Clínica Universitaria de Navarra | Pamplona | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital General de Segovia | Segovia | Segovia | 40002 | Spain |
| Hospital Universitario Río Hortega | Valladolid | Valladolid | 47010 | Spain |
| Hospital Universitario Virgen de la Concha | Zamora | Zamora | 49022 | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| 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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