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

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (Other)

Overall Status

Completed

CT.gov ID

NCT01562977

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2011

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
2	Hospital Duran i Reynals	Sabadell	Barcelona	Spain
3	Hospital SAS de Jerez	Jerez de la Frontera	Cádiz	Spain
4	Hospital Dr. Jose Molina Orosa	Arrecife	Lanzarote	Spain
5	Fundación Hospital de Alcorcón	Alcorcón	Madrid	Spain
6	Hospital Puerta de Hierro de Majadahonda	Majadahonda	Madrid	Spain
7	Hospital Virgen de Arrixaca	El Palmar	Murcia	Spain
8	Complejo Hospitalario de A Coruña	A Coruña		Spain
9	Hospital Santa Creu i Sant Pau	Barcelona		Spain
10	Hospital Vall d´Hebrón	Barcelona		Spain
11	Hospital 12 Octubre	Madrid		Spain
12	Hospital Gregorio Marañón	Madrid		Spain
13	Hospital La Paz	Madrid		Spain
14	Hospital Ramón y Cajal	Madrid		Spain
15	Hospital Morales Meseguer	Murcia		Spain
16	Hospital Son Espasses	Palma de Mallorca		Spain
17	Hospital Son Llàtzer	Palma de Mallorca		Spain
18	Clinica Universitaria de Navarra	Pamplona		Spain
19	Corporació Sanitari Parc Taulí	Sabadell		Spain
20	Hospital Clínico de Salamanca	Salamanca		Spain
21	Hospital Universitario de Canarias	Santa Cruz de Tenerife		Spain
22	Hospital Marqués de Valdecilla	Santander		Spain
23	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela		Spain
24	Hospital Dr. Peset	Valencia		Spain
25	Hospital La Fe	Valencia		Spain
26	Hospital Virgen de la Concha	Zamora		Spain
27	Hospital Clínico Lozano Blesa	Zaragoza		Spain
28	Hospital Miguel Servet	Zaragoza		Spain

Sponsors and Collaborators

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

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