Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
The purpose of this study is to determine efficacy (overall response rate (ORR) and complete response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no arms | Other | no arms were present for the study, only 2 different cohorts:MCL and LDCGB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab, Gemcitabine, Oxaliplatin, Dexametasone | Drug | until progression or unacceptable toxicity develops, 8 cicles max Rituximab: 375 mg/m2, IV, day 1. Gemcitabine: 1000 mg/m2, IV, day 2. Oxaliplatin: 100 mg/m2, IV, day 2. Dexametasone: 20 mg/day, days 1-3, oral. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is to evaluate Overall response rate (ORR) | The primary endpoint is to evaluate the number of patients with complete remission, unconfirmed complete remission and partial response according to International Workshop to Standardize Response Criteria for NHL, of R-GEMOX combination administered every 14 days | 3 years and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx) | To asses the number of Participants with Adverse Events (serious and non serious) and classification of those adverse events. Evaluate if the balance efficacy / toxicity allows the possibility of further interventions to prolong progression-free survival and overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrés López Hernández, MD | Hospital Vall d´Hebrón | Principal Investigator |
| Mª Dolores Caballero Barrigón, MD | Hospital Clínico de Salamanca | Principal Investigator |
| Jorge Gayoso Cruz, MD | Hospital Universitario Gregorio Marañón | Principal Investigator |
| Juan Alfonso Soler Campos, MD | Corporació Sanitari Parc Taulí | Principal Investigator |
| Carlos Montalbán Sanz, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Juan Manuel Sancho Cía, MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Isidro Jarque, MD | Hospital Universitario La Fe | Principal Investigator |
| Secundino Ferrer, MD | Hospital Dr. Peset | Principal Investigator |
| Carlos Grande, MD | Hospital 12 de Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | |||
| Hospital Duran i Reynals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years and 2 months |
| To identify clinical response predictive factors | To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response. | 3 years 2 months |
| Pilar Martínez Barranco, MD |
| Fundación Hospital de Alcorcón |
| Principal Investigator |
| Miguel Ángel Canales Albendea, MD | Hospital La Paz | Principal Investigator |
| Jose Antonio García Marco, MD | Hospital Puerta de Hierro de Majadahonda | Principal Investigator |
| Roberto Hernández Martín, MD | Hospital Virgen de la Concha | Principal Investigator |
| José Manuel Calvo Villas, MD | Hospital Dr. Jose Molina Orosa | Principal Investigator |
| Miguel Hernández, García | Hospital Universitario de Canarias | Principal Investigator |
| Elena Pérez Ceballos, MD | Hospital Morales Meseguer | Principal Investigator |
| José M. Moraleda Jiménez, MD | Hospital Virgen de la Arrixaca | Principal Investigator |
| Eulogio Conde García, MD | Hospital Marqués de Valdecilla | Principal Investigator |
| Carlos Panizo Santos, MD | Clínica Universitaria Navarra | Principal Investigator |
| Mª Rosario Varela, MD | Complejo Hospitalario A Coruña | Principal Investigator |
| Jose Luis Bello López, MD | Complejo Hospitalario Universitario de Santiago | Principal Investigator |
| Maria José Ramírez Sánchez, MD | Hospital del SAS Jerez | Principal Investigator |
| Luis Palomera, MD | Hospital Clínico Lozano Blesa | Principal Investigator |
| Pilar Giraldo, MD | Hospital Miguel Servet | Principal Investigator |
| Antonio Gutiérrez, MD | Hospital Son Espasses | Principal Investigator |
| Joan Bargay Leonart, MD | Hospital Son Llàtzer | Principal Investigator |
| Eva González Barca, MD | Hospital Duran i Reynals | Principal Investigator |
| Javier Briones Meijide, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Sabadell |
| Barcelona |
| Spain |
| Hospital SAS de Jerez | Jerez de la Frontera | Cádiz | Spain |
| Hospital Dr. Jose Molina Orosa | Arrecife | Lanzarote | Spain |
| Fundación Hospital de Alcorcón | Alcorcón | Madrid | Spain |
| Hospital Puerta de Hierro de Majadahonda | Majadahonda | Madrid | Spain |
| Hospital Virgen de Arrixaca | El Palmar | Murcia | Spain |
| Complejo Hospitalario de A Coruña | A Coruña | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Vall d´Hebrón | Barcelona | Spain |
| Hospital 12 Octubre | Madrid | Spain |
| Hospital Gregorio Marañón | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Morales Meseguer | Murcia | Spain |
| Hospital Son Espasses | Palma de Mallorca | Spain |
| Hospital Son Llàtzer | Palma de Mallorca | Spain |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| Corporació Sanitari Parc Taulí | Sabadell | Spain |
| Hospital Clínico de Salamanca | Salamanca | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
| Hospital Marqués de Valdecilla | Santander | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Spain |
| Hospital Dr. Peset | Valencia | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital Virgen de la Concha | Zamora | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | Spain |
| Hospital Miguel Servet | Zaragoza | Spain |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| 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 |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided