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Completed

NCT Number: NCT01562977

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

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

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Key information

Conditions

Aggressive Lymphoma Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

Drug

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.

Primary outcomes

  1. The primary endpoint is to evaluate Overall response rate (ORR)

    Time frame: 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 outcomes

  1. Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)

    Time frame: 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

  2. To identify clinical response predictive factors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Other

Registry information

Official study 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

Acronym: RGemOx

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2012
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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