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

October 27, 2017 updated by: Ana Mendez Lopez, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario de A Coruña
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall D´Hebron
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital 12 Octubre
      • Murcia, Spain
        • Hospital Morales Meseguer
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain
        • Hospital Son Espasses
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
      • Sabadell, Spain
        • Corporacio Sanitari Parc Tauli
      • Salamanca, Spain
        • Hospital Clínico de Salamanca
      • Santa Cruz de Tenerife, Spain
        • Hospital Universitario de Canarias
      • Santander, Spain
        • Hospital Marqués de Valdecilla
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital Dr. Peset
      • Zamora, Spain
        • Hospital Virgen de la Concha
      • Zaragoza, Spain
        • Hospital Miguel Servet
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trías i Pujol
      • Sabadell, Barcelona, Spain
        • Hospital Duran i Reynals
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain
        • Hospital SAS de Jerez
    • Lanzarote
      • Arrecife, Lanzarote, Spain
        • Hospital Dr. José Molina Orosa
    • Madrid
      • Alcorcón, Madrid, Spain
        • Fundacion Hospital de Alcorcon
      • Majadahonda, Madrid, Spain
        • Hospital Puerta de Hierro de Majadahonda
    • Murcia
      • El Palmar, Murcia, Spain
        • Hospital Virgen de Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: no arms
no arms were present for the study, only 2 different cohorts:MCL and LDCGB
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint is to evaluate Overall response rate (ORR)
Time Frame: 3 years and 2 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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
3 years and 2 months
To identify clinical response predictive factors
Time Frame: 3 years 2 months
To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response.
3 years 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrés López Hernández, MD, Hospital Vall D´Hebron
  • 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, Corporacio Sanitari Parc Tauli
  • Principal Investigator: Carlos Montalbán Sanz, MD, Hospital Universitario Ramon y Cajal
  • Principal Investigator: Juan Manuel Sancho Cia, 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, Fundacion Hospital de Alcorcon
  • 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. José 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 Clinico 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 Llatzer
  • Principal Investigator: Eva González Barca, MD, Hospital Duran i Reynals
  • Principal Investigator: Javier Briones Meijide, MD, Hospital Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GEL-TAMO/R-GemOx-08-04/v2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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