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

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Status and phase: Completed; Phase 2

Conditions: Aggressive Lymphoma; Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma

Treatments: Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01562977

GEL-TAMO/R-GemOx-08-04/v2

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

no arms

Other group

Description:

no arms were present for the study, only 2 different cohorts:MCL and LDCGB

Treatment:

Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone