Trial | NCT01562977  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    82
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
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 Started
Apr 30
2011
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Oct 30
2017

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.

no arms Other

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

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).
No Results Posted