Clinical trial · Interventional
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
NCT01562977CI-TRIAL-00030113RGemOxcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Lymphoma | Aggressive Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab, Gemcitabine, Oxaliplatin, Dexametasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- no arms
- description
- no arms were present for the study, only 2 different cohorts:MCL and LDCGB
- interventionNames
- Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone
Primary outcomes (1)
- measure
- The primary endpoint is to evaluate Overall response rate (ORR)
- timeFrame
- 3 years and 2 months
- description
- 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 (2)
- measure
- Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.