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

Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study ID
NCT01562977
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Apr 30, 2011
Status verified
Oct 2017
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
82 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

The primary endpoint is to evaluate Overall response rate (ORR) [ Time Frame: 3 years and 2 months ]

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