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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:
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
History of Changes

July 18, 2011
July 23, 2012
April 2011
April 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01562977 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL
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

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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aggressive Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Mantle Cell Lymphoma
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
129
April 2017
April 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Andrés López, MD andlopez@vhebron.net
Spain
 
NCT01562977
GEL-TAMO/R-GemOx-08-04/v2
Not Provided
Ana Mendez Lopez, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Not Provided
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
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP