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

NCT ID: NCT01562977

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Aggressive Lymphoma Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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no arms

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

Group Type OTHER

Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

Sponsor Role lead

Responsible Party

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Ana Mendez Lopez

Sponsor's secretary

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrés López Hernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d´Hebrón

Mª Dolores Caballero Barrigón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico de Salamanca

Jorge Gayoso Cruz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Gregorio Marañón

Juan Alfonso Soler Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Corporació Sanitari Parc Taulí

Carlos Montalbán Sanz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Juan Manuel Sancho Cía, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Isidro Jarque, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Fe de Valencia

Secundino Ferrer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Peset

Carlos Grande, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre

Pilar Martínez Barranco, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Hospital de Alcorcón

Miguel Ángel Canales Albendea, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Paz

Jose Antonio García Marco, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro de Majadahonda

Roberto Hernández Martín, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Concha

José Manuel Calvo Villas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Jose Molina Orosa

Miguel Hernández, García

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Canarias

Elena Pérez Ceballos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Morales Meseguer

José M. Moraleda Jiménez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Arrixaca

Eulogio Conde García, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Marqués de Valdecilla

Carlos Panizo Santos, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Universitaria Navarra

Mª Rosario Varela, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario A Coruña

Jose Luis Bello López, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago

Maria José Ramírez Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del SAS Jerez

Luis Palomera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Lozano Blesa

Pilar Giraldo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Antonio Gutiérrez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Espasses

Joan Bargay Leonart, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Llàtzer

Eva González Barca, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Duran i Reynals

Javier Briones Meijide, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Duran i Reynals

Sabadell, Barcelona, Spain

Site Status

Hospital SAS de Jerez

Jerez de la Frontera, Cádiz, Spain

Site Status

Hospital Dr. Jose Molina Orosa

Arrecife, Lanzarote, Spain

Site Status

Fundación Hospital de Alcorcón

Alcorcón, Madrid, Spain

Site Status

Hospital Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Site Status

Hospital Virgen de Arrixaca

El Palmar, Murcia, Spain

Site Status

Complejo Hospitalario de A Coruña

A Coruña, , Spain

Site Status

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Vall d´Hebrón

Barcelona, , Spain

Site Status

Hospital 12 Octubre

Madrid, , Spain

Site Status

Hospital Gregorio Marañón

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Morales Meseguer

Murcia, , Spain

Site Status

Hospital Son Espasses

Palma de Mallorca, , Spain

Site Status

Hospital Son Llàtzer

Palma de Mallorca, , Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, , Spain

Site Status

Corporació Sanitari Parc Taulí

Sabadell, , Spain

Site Status

Hospital Clínico de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Marqués de Valdecilla

Santander, , Spain

Site Status

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Site Status

Hospital Dr. Peset

Valencia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Hospital Virgen de la Concha

Zamora, , Spain

Site Status

Hospital Clínico Lozano Blesa

Zaragoza, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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GEL-TAMO/R-GemOx-08-04/v2

Identifier Type: -

Identifier Source: org_study_id