RGemOx: Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL
Study Details
Study Description
Brief Summary
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: no arms no arms were present for the study, only 2 different cohorts:MCL and LDCGB |
Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone
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.
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Outcome Measures
Primary Outcome Measures
- The primary endpoint is to evaluate Overall response rate (ORR) [3 years and 2 months]
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
Secondary Outcome Measures
- Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx) [3 years and 2 months]
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
- To identify clinical response predictive factors [3 years 2 months]
To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years.
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DLBCL and MCL diagnosed patients in primary resistance or relapsed not eligible for intensification chemotherapy followed by Autologous stem cell transplantation (ASCT) for age, comorbidity or previous ASCT.
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Any IPI or ECOG, capable of understanding the nature of the trial.
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Writtern Informed Consent.
Exclusion Criteria:
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Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
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CNS lymphoma patients.
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Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST> 2,5 UNL) impairement not provided by the same disease
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HIV positive patients.
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Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
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Murine proteins or any other component of the medicines of the study hypersensitivity patients.
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Patients who have received more than 2 therapeutic previous lines. (for previous ASCT patients, induction and conditioning for the TAPH treatment is considered a single line therapy).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | |
2 | Hospital Duran i Reynals | Sabadell | Barcelona | Spain | |
3 | Hospital SAS de Jerez | Jerez de la Frontera | Cádiz | Spain | |
4 | Hospital Dr. Jose Molina Orosa | Arrecife | Lanzarote | Spain | |
5 | Fundación Hospital de Alcorcón | Alcorcón | Madrid | Spain | |
6 | Hospital Puerta de Hierro de Majadahonda | Majadahonda | Madrid | Spain | |
7 | Hospital Virgen de Arrixaca | El Palmar | Murcia | Spain | |
8 | Complejo Hospitalario de A Coruña | A Coruña | Spain | ||
9 | Hospital Santa Creu i Sant Pau | Barcelona | Spain | ||
10 | Hospital Vall d´Hebrón | Barcelona | Spain | ||
11 | Hospital 12 Octubre | Madrid | Spain | ||
12 | Hospital Gregorio Marañón | Madrid | Spain | ||
13 | Hospital La Paz | Madrid | Spain | ||
14 | Hospital Ramón y Cajal | Madrid | Spain | ||
15 | Hospital Morales Meseguer | Murcia | Spain | ||
16 | Hospital Son Espasses | Palma de Mallorca | Spain | ||
17 | Hospital Son Llàtzer | Palma de Mallorca | Spain | ||
18 | Clinica Universitaria de Navarra | Pamplona | Spain | ||
19 | Corporació Sanitari Parc Taulí | Sabadell | Spain | ||
20 | Hospital Clínico de Salamanca | Salamanca | Spain | ||
21 | Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain | ||
22 | Hospital Marqués de Valdecilla | Santander | Spain | ||
23 | Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Spain | ||
24 | Hospital Dr. Peset | Valencia | Spain | ||
25 | Hospital La Fe | Valencia | Spain | ||
26 | Hospital Virgen de la Concha | Zamora | Spain | ||
27 | Hospital Clínico Lozano Blesa | Zaragoza | Spain | ||
28 | Hospital Miguel Servet | Zaragoza | Spain |
Sponsors and Collaborators
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
- Principal Investigator: 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 La Fe de Valencia
- Principal Investigator: Secundino Ferrer, MD, Hospital Dr. Peset
- Principal Investigator: Carlos Grande, MD, Hospital 12 de Octubre
- Principal Investigator: 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, Hospital Santa Creu i Sant Pau
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GEL-TAMO/R-GemOx-08-04/v2