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

Study Overview
=================
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.

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

Conditions
-----------------
Mantle Cell Lymphoma, Aggressive Lymphoma, Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no arms<br>no arms were present for the study, only 2 different cohorts:MCL and LDCGB | Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone<br>* 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.<br>|

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 |