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

Mantle Cell Lymphoma Clinical Trial

— RGemOx  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562977
• Other study ID #: GEL-TAMO/R-GemOx-08-04/v2
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2011
• Last updated: October 27, 2017
• Start date: April 2011
• Est. completion date: April 2015

Study information

• Verified date: October 2017
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de A Coruña	A Coruña
Spain	Fundación Hospital de Alcorcón	Alcorcón	Madrid
Spain	Hospital Dr. Jose Molina Orosa	Arrecife	Lanzarote
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d´Hebrón	Barcelona
Spain	Hospital Virgen de Arrixaca	El Palmar	Murcia
Spain	Hospital SAS de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital 12 Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Puerta de Hierro de Majadahonda	Majadahonda	Madrid
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Son Espasses	Palma de Mallorca
Spain	Hospital Son Llàtzer	Palma de Mallorca
Spain	Clinica Universitaria de Navarra	Pamplona
Spain	Corporació Sanitari Parc Taulí	Sabadell
Spain	Hospital Duran i Reynals	Sabadell	Barcelona
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital Dr. Peset	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Virgen de la Concha	Zamora
Spain	Hospital Clínico Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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