Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL (RGemOx)
This study is currently recruiting participants.
Verified July 2012 by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by (Responsible Party):
Ana Mendez Lopez, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01562977
First received: July 18, 2011
Last updated: July 23, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
| Condition | Intervention | Phase |
|---|---|---|
|
Aggressive Lymphoma Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma |
Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted |
Resource links provided by NLM:
Further study details as provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Primary Outcome Measures:
- The primary endpoint is to evaluate Overall response rate (ORR) [ Time Frame: 3 years and 2 months ] [ Designated as safety issue: No ]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) [ Time Frame: 3 years and 2 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 years 2 months ] [ Designated as safety issue: No ]To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response.
| Estimated Enrollment: | 129 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- 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.
- Any IPI or ECOG, capable of understanding the nature of the trial.
- Writtern Informed Consent.
Exclusion Criteria:
- Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
- CNS lymphoma patients.
- Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST> 2,5 UNL) impairement not provided by the same disease
- HIV positive patients.
- Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
- Murine proteins or any other component of the medicines of the study hypersensitivity patients.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562977
Contacts
| Contact: Andrés López, MD | andlopez@vhebron.net |
Locations
| Spain | |
| Hospital Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain | |
| Contact: Juan Manuel Sancho, MD jsancho@iconcologia.net | |
| Contact jsancho@iconcologia.net | |
| Hospital Duran i Reynals | Recruiting |
| Sabadell, Barcelona, Spain | |
| Contact: Eva González, MD e.gonzalez@ico.scs.es | |
| Contact e.gonzalez@ico.scs.es | |
| Hospital SAS de Jerez | Recruiting |
| Jerez de la Frontera, Cádiz, Spain | |
| Contact: Maria José Ramírez, MD mariajoserasa@yahoo.es | |
| Contact mariajoserasa@yahoo.es | |
| Fundación Hospital de Alcorcón | Recruiting |
| Alcorcón, Madrid, Spain | |
| Contact: Pilar Martínez, MD pmartinez@fhalcorcon.es | |
| Contact pmartinez@fhalcorcon.es | |
| Hospital Puerta de Hierro de Majadahonda | Recruiting |
| Majadahonda, Madrid, Spain | |
| Contact: José Antonio García Marco, MD jagarciam@aehh.org | |
| Contact jagarciam@aehh.org | |
| Hospital Virgen de Arrixaca | Enrolling by invitation |
| El Palmar, Murcia, Spain | |
| Complejo Hospitalario de A Coruña | Enrolling by invitation |
| A Coruña, Spain | |
| Hospital Vall d´Hebrón | Recruiting |
| Barcelona, Spain | |
| Contact: Andrés López, MD andlopez@vhebron.net | |
| Contact andlopez@vhebron.net | |
| Hospital Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain | |
| Contact: Javier Briones, MD jbriones@hsp.santpau.es | |
| Contact jbriones@hsp.santpau.es | |
| Hospital Dr. Jose Molina Orosa | Recruiting |
| Lanzarote, Spain | |
| Contact: Jose Manuel Calvo, MD jmcvillas@hotmail.com | |
| Contact jmcvillas@hotmail.com | |
| Hospital Ramón y Cajal | Recruiting |
| Madrid, Spain | |
| Contact: Carlos Montalbán, MD cmontalban.hrc@salud.madrid.org | |
| Contact cmontalban.hrc@salud.madrid.org | |
| Hospital Gregorio Marañón | Recruiting |
| Madrid, Spain | |
| Contact: Jorge Gayoso, MD jgayoso.hgugm@salud.madrid.org | |
| Contact jgayoso.hgugm@salud.madrid.org | |
| Hospital 12 Octubre | Recruiting |
| Madrid, Spain | |
| Contact: Carlos Grande, MD cgrande.hdoc@salud.madrid.org | |
| Contact cgrande.hdoc@salud.madrid.org | |
| Hospital La Paz | Recruiting |
| Madrid, Spain | |
| Contact: Miguel Ángel, MD mcanales.hulp@salud.madrid.org | |
| Contact mcanales.hulp@salud.madrid.org | |
| Hospital Morales Meseguer | Recruiting |
| Murcia, Spain | |
| Contact: Elena Pérez, MD elena.perez@carm.es | |
| Contact elena.perez@carm.es | |
| Hospital Son Espasses | Recruiting |
| Palma de Mallorca, Spain | |
| Contact: Antonio Gutiérrez, MD antoniom.gutierrez@ssib.es | |
| Contact antoniom.gutierrez@ssib.es | |
| Hospital Son Llàtzer | Recruiting |
| Palma de Mallorca, Spain | |
| Contact: Joan Bargay, MD jbargay@hsll.es | |
| Contact jbargay@hsll.es | |
| Clinica Universitaria de Navarra | Recruiting |
| Pamplona, Spain | |
| Contact: Carlos Panizo, MD cpanizo@unav.es | |
| Contact cpanizo@unav.es | |
| Corporació Sanitari Parc Taulí | Recruiting |
| Sabadell, Barcelona, Spain | |
| Contact: Juan Alfonso Soler, MD jsoler@tauli.cat | |
| Contact jsoler@tauli.cat | |
| Hospital Clínico de Salamanca | Recruiting |
| Salamanca, Spain | |
| Contact: Mª Dolores Caballero, MD cabarri@usal.es | |
| Contact cabarri@usal.es | |
| Hospital Universitario de Canarias | Recruiting |
| Santa Cruz de Tenerife, Spain | |
| Contact: Miguel Hernández, MD mthernandez@huc.canarias.org | |
| Contact mthernandez@huc.canarias.org | |
| Hospital Marqués de Valdecilla | Recruiting |
| Santander, Spain | |
| Contact: Eulogio Conde, MD hemcge@humv.es | |
| Contact hemcge@humv.es | |
| Complejo Hospitalario Universitario de Santiago | Recruiting |
| Santiago de Compostela, Spain | |
| Contact: Jose Luis Bello, MD joseluis.bello@usc.es | |
| Contact joseluis.bello@usc.es | |
| Hospital Dr. Peset | Recruiting |
| Valencia, Spain | |
| Contact: Secundino Ferrer, MD ferrer_sec@gva.es | |
| Contact ferrer_sec@gva.es | |
| Hospital La Fe | Recruiting |
| Valencia, Spain | |
| Contact: Isidro Jarque, MD jarque_isi@gva.es | |
| Contact jarque_isi@gva.es | |
| Hospital Virgen de la Concha | Not yet recruiting |
| Zamora, Spain | |
| Contact: Roberto Hernández, MD amartin@hvcn.sacyl.es | |
| Contact amartin@hvcn.sacyl.es | |
| Hospital Miguel Servet | Recruiting |
| Zaragoza, Spain | |
| Contact: Pilar Giraldo, MD pgiraldoc@medynet.com | |
| Contact pgiraldoc@medynet.com | |
| Hospital Clínico Lozano Blesa | Recruiting |
| Zaragoza, Spain | |
| Contact: Luis Palomera, MD lpalomera@salud.aragon.es | |
| Contact lpalomera@salud.aragon.es | |
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 Ramón y Cajal |
| Principal Investigator: | Juan Manuel Sancho Cía, MD | HOSPITAL GERMANS TRIAS I PUJOL |
| 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 |
More Information
No publications provided
| Responsible Party: | Ana Mendez Lopez, Sponsor's secretary, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
| ClinicalTrials.gov Identifier: | NCT01562977 History of Changes |
| Other Study ID Numbers: | GEL-TAMO/R-GemOx-08-04/v2 |
| Study First Received: | July 18, 2011 |
| Last Updated: | July 23, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Aggression Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Behavioral Symptoms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Gemcitabine Oxaliplatin |
Rituximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013