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

NCT01562977 | Completed Phase 2

• 1 other identifier: GEL-TAMO/R-GemOx-08-04/v2
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 28

Brief Summary

The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.

Conditions

Aggressive Lymphoma; Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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 identify clinical response predictive factors

  3 years 2 months

Study Arms (1)

no arms

OTHER

no arms were present for the study, only 2 different cohorts:MCL and LDCGB

Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

Interventions

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.

no arms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead

Study Sites (28)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital Duran i Reynals

Sabadell, Barcelona, Spain

Location

Hospital SAS de Jerez

Jerez de la Frontera, Cádiz, Spain

Location

Hospital Dr. Jose Molina Orosa

Arrecife, Lanzarote, Spain

Location

Fundación Hospital de Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Location

Hospital Virgen de Arrixaca

El Palmar, Murcia, Spain

Location

Complejo Hospitalario de A Coruña

A Coruña, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Vall d´Hebrón

Barcelona, Spain

Location

Hospital 12 Octubre

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Morales Meseguer

Murcia, Spain

Location

Hospital Son Espasses

Palma de Mallorca, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Corporació Sanitari Parc Taulí

Sabadell, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Marqués de Valdecilla

Santander, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Dr. Peset

Valencia, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Virgen de la Concha

Zamora, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell

Interventions

Rituximab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• 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

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor's secretary

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: March 26, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

ES (28)