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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562977

Acronym

RGemOx

Enrollment

Registered

2012-03-26

Start date

2011-04-30

Completion date

2015-04-30

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed 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.

Interventions

DRUGRituximab, 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
The primary endpoint is to evaluate Overall response rate (ORR)	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

Measure	Time frame	Description
Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)	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
To identify clinical response predictive factors	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026