Back to resultsStudy to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL (RGemOx)
Primary Purpose
Aggressive Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Rituximab, Gemcitabine, Oxaliplatin, Dexametasone
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Hospital Germans Trias i Pujol
- Hospital Duran i Reynals
- Hospital SAS de Jerez
- Hospital Dr. Jose Molina Orosa
- Fundación Hospital de Alcorcón
- Hospital Puerta de Hierro de Majadahonda
- Hospital Virgen de Arrixaca
- Complejo Hospitalario de A Coruña
- Hospital Santa Creu i Sant Pau
- Hospital Vall d´Hebrón
- Hospital 12 Octubre
- Hospital Gregorio Marañón
- Hospital La Paz
- Hospital Ramón y Cajal
- Hospital Morales Meseguer
- Hospital Son Espasses
- Hospital Son Llàtzer
- Clinica Universitaria de Navarra
- Corporació Sanitari Parc Taulí
- Hospital Clínico de Salamanca
- Hospital Universitario de Canarias
- Hospital Marqués de Valdecilla
- Complejo Hospitalario Universitario de Santiago
- Hospital Dr. Peset
- Hospital La Fe
- Hospital Virgen de la Concha
- Hospital Clínico Lozano Blesa
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
no arms
Arm Description
no arms were present for the study, only 2 different cohorts:MCL and LDCGB
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)
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
To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response.
Full Information
NCT ID
NCT01562977
First Posted
July 18, 2011
Last Updated
October 27, 2017
Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
1. Study Identification
Unique Protocol Identification Number
NCT01562977
Brief Title
Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL
Acronym
RGemOx
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no arms
Arm Type
Other
Arm Description
no arms were present for the study, only 2 different cohorts:MCL and LDCGB
Intervention Type
Drug
Intervention Name(s)
Rituximab, Gemcitabine, Oxaliplatin, Dexametasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint is to evaluate Overall response rate (ORR)
Description
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
Time Frame
3 years and 2 months
Secondary Outcome Measure Information:
Title
Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)
Description
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
Time Frame
3 years and 2 months
Title
To identify clinical response predictive factors
Description
To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response.
Time Frame
3 years 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés López Hernández, MD
Organizational Affiliation
Hospital Vall d´Hebrón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Dolores Caballero Barrigón, MD
Organizational Affiliation
Hospital Clínico de Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge Gayoso Cruz, MD
Organizational Affiliation
Hospital Universitario Gregorio Marañón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Alfonso Soler Campos, MD
Organizational Affiliation
Corporació Sanitari Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Montalbán Sanz, MD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Manuel Sancho Cía, MD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isidro Jarque, MD
Organizational Affiliation
Hospital La Fe de Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Secundino Ferrer, MD
Organizational Affiliation
Hospital Dr. Peset
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Grande, MD
Organizational Affiliation
Hospital 12 de Octubre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pilar Martínez Barranco, MD
Organizational Affiliation
Fundación Hospital de Alcorcón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Canales Albendea, MD
Organizational Affiliation
Hospital La Paz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Antonio García Marco, MD
Organizational Affiliation
Hospital Puerta de Hierro de Majadahonda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Hernández Martín, MD
Organizational Affiliation
Hospital Virgen de la Concha
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Manuel Calvo Villas, MD
Organizational Affiliation
Hospital Dr. Jose Molina Orosa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel Hernández, García
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena Pérez Ceballos, MD
Organizational Affiliation
Hospital Morales Meseguer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José M. Moraleda Jiménez, MD
Organizational Affiliation
Hospital Virgen de la Arrixaca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eulogio Conde García, MD
Organizational Affiliation
Hospital Marqués de Valdecilla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Panizo Santos, MD
Organizational Affiliation
Clínica Universitaria Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Rosario Varela, MD
Organizational Affiliation
Complejo Hospitalario A Coruña
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Luis Bello López, MD
Organizational Affiliation
Complejo Hospitalario Universitario de Santiago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria José Ramírez Sánchez, MD
Organizational Affiliation
Hospital del SAS Jerez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Palomera, MD
Organizational Affiliation
Hospital Clínico Lozano Blesa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pilar Giraldo, MD
Organizational Affiliation
Hospital Miguel Servet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Gutiérrez, MD
Organizational Affiliation
Hospital Son Espasses
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Bargay Leonart, MD
Organizational Affiliation
Hospital Son Llàtzer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva González Barca, MD
Organizational Affiliation
Hospital Duran i Reynals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Briones Meijide, MD
Organizational Affiliation
Hospital Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital SAS de Jerez
City
Jerez de la Frontera
State/Province
Cádiz
Country
Spain
Facility Name
Hospital Dr. Jose Molina Orosa
City
Arrecife
State/Province
Lanzarote
Country
Spain
Facility Name
Fundación Hospital de Alcorcón
City
Alcorcón
State/Province
Madrid
Country
Spain
Facility Name
Hospital Puerta de Hierro de Majadahonda
City
Majadahonda
State/Province
Madrid
Country
Spain
Facility Name
Hospital Virgen de Arrixaca
City
El Palmar
State/Province
Murcia
Country
Spain
Facility Name
Complejo Hospitalario de A Coruña
City
A Coruña
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d´Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital 12 Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
Country
Spain
Facility Name
Hospital Son Espasses
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Corporació Sanitari Parc Taulí
City
Sabadell
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL
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