Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL (RGemOx)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor:
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: August 22, 2013
Last verified: August 2013
  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:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. 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.
  3. Any IPI or ECOG, capable of understanding the nature of the trial.
  4. Writtern Informed Consent.

Exclusion Criteria:

  1. Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
  2. CNS lymphoma patients.
  3. Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST> 2,5 UNL) impairement not provided by the same disease
  4. HIV positive patients.
  5. Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
  6. Murine proteins or any other component of the medicines of the study hypersensitivity patients.
  7. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 La Paz Recruiting
Madrid, Spain
Contact: Miguel Ángel, MD       mcanales.hulp@salud.madrid.org   
Contact       mcanales.hulp@salud.madrid.org   
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 Morales Meseguer Recruiting
Murcia, Spain
Contact: Elena Pérez, MD       elena.perez@carm.es   
Contact       elena.perez@carm.es   
Hospital Son Llàtzer Recruiting
Palma de Mallorca, Spain
Contact: Joan Bargay, MD       jbargay@hsll.es   
Contact       jbargay@hsll.es   
Hospital Son Espasses Recruiting
Palma de Mallorca, Spain
Contact: Antonio Gutiérrez, MD       antoniom.gutierrez@ssib.es   
Contact       antoniom.gutierrez@ssib.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 La Fe Recruiting
Valencia, Spain
Contact: Isidro Jarque, MD       jarque_isi@gva.es   
Contact       jarque_isi@gva.es   
Hospital Dr. Peset Recruiting
Valencia, Spain
Contact: Secundino Ferrer, MD       ferrer_sec@gva.es   
Contact       ferrer_sec@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 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
  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: August 22, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Gemcitabine
Oxaliplatin
Rituximab
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014