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

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: Completed
• Conditions: Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Aggressive Lymphoma
• Intervention / Treatment: Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

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: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

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 Ramón y Cajal
  • Madrid, Spain
    • Hospital Gregorio Marañon
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain
    • Hospital 12 Octubre
  • Murcia, Spain
    • Hospital Morales Meseguer
  • Palma de Mallorca, Spain
    • Hospital Son Llàtzer
  • 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 Marques de Valdecilla
  • Santiago de Compostela, Spain
    • Complejo Hospitalario Universitario de Santiago
  • Valencia, Spain
    • Hospital la Fé
  • 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 Trias 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	3 years and 2 months

Secondary Outcome Measures

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)	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	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

• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Investigators: 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 Maranon; Principal Investigator: Juan Alfonso Soler Campos, MD, Corporacio Sanitari Parc Tauli; Principal Investigator: Carlos Montalbán Sanz, MD, Hospital Universitario Ramón 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 Marques 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 Llàtzer; 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

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Gemcitabine; Oxaliplatin; Rituximab
• Other Study ID Numbers: GEL-TAMO/R-GemOx-08-04/v2