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

Phase 2

Completed

• Conditions: Aggressive Lymphoma; Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma
• Interventions: Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

• Registration Number: NCT01562977
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
no arms	Rituximab, Gemcitabine, Oxaliplatin, Dexametasone	no arms were present for the study, only 2 different cohorts:MCL and LDCGB

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to evaluate Overall response rate (ORR)	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

Name	Time	Method
Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)	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
To identify clinical response predictive factors	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.

Trial Locations

Locations (28)

Hospital SAS de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Dr. Peset; 🇪🇸 Valencia, Spain

Complejo Hospitalario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Duran i Reynals; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Dr. Jose Molina Orosa; 🇪🇸 Arrecife, Lanzarote, Spain

Fundación Hospital de Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Puerta de Hierro de Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Virgen de Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Son Llàtzer; 🇪🇸 Palma de Mallorca, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Vall d´Hebrón; 🇪🇸 Barcelona, Spain

Hospital 12 Octubre; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Son Espasses; 🇪🇸 Palma de Mallorca, Spain

Hospital Morales Meseguer; 🇪🇸 Murcia, Spain

Corporació Sanitari Parc Taulí; 🇪🇸 Sabadell, Spain

Hospital Clínico de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Spain

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Virgen de la Concha; 🇪🇸 Zamora, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain