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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562977
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Ana Mendez Lopez, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

Condition or disease Intervention/treatment Phase
Aggressive Lymphoma Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562977

Show Show 28 study locations
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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Principal Investigator: 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 Hospital Santa Creu i Sant Pau
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Responsible Party: Ana Mendez Lopez, Sponsor's secretary, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea Identifier: NCT01562977    
Other Study ID Numbers: GEL-TAMO/R-GemOx-08-04/v2
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents