Clinical trial NCT01562977: Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aggressive Lymphoma
Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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).

Primary outcomes:
measure: The primary endpoint is to evaluate Overall response rate (ORR)
timeFrame: 3 years and 2 months
Secondary outcomes:
measure: Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)
timeFrame: 3 years and 2 months
measure: To identify clinical response predictive factors
timeFrame: 3 years 2 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Duran i Reynals
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital SAS de Jerez
state: Cádiz
city: Arrecife
country: Spain
facility: Hospital Dr. Jose Molina Orosa
state: Lanzarote
city: Alcorcón
country: Spain
facility: Fundación Hospital de Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro de Majadahonda
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Virgen de Arrixaca
state: Murcia
city: A Coruña
country: Spain
facility: Complejo Hospitalario de A Coruña
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebrón
city: Madrid
country: Spain
facility: Hospital 12 Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espasses
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Sabadell
country: Spain
facility: Corporació Sanitari Parc Taulí
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Vall d´Hebrón
name: Andrés López Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Salamanca
name: Mª Dolores Caballero Barrigón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Gregorio Marañón
name: Jorge Gayoso Cruz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporació Sanitari Parc Taulí
name: Juan Alfonso Soler Campos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Carlos Montalbán Sanz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Juan Manuel Sancho Cía, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Fe de Valencia
name: Isidro Jarque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Dr. Peset
name: Secundino Ferrer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Carlos Grande, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Hospital de Alcorcón
name: Pilar Martínez Barranco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Paz
name: Miguel Ángel Canales Albendea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro de Majadahonda
name: Jose Antonio García Marco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Concha
name: Roberto Hernández Martín, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Dr. Jose Molina Orosa
name: José Manuel Calvo Villas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Canarias
name: Miguel Hernández, García
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Morales Meseguer
name: Elena Pérez Ceballos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Arrixaca
name: José M. Moraleda Jiménez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: Eulogio Conde García, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universitaria Navarra
name: Carlos Panizo Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario A Coruña
name: Mª Rosario Varela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Santiago
name: Jose Luis Bello López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del SAS Jerez
name: Maria José Ramírez Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Lozano Blesa
name: Luis Palomera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Miguel Servet
name: Pilar Giraldo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espasses
name: Antonio Gutiérrez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Llàtzer
name: Joan Bargay Leonart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Duran i Reynals
name: Eva González Barca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Javier Briones Meijide, MD
role: PRINCIPAL_INVESTIGATOR
References: