Clinical trial · Interventional
DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma
Treatment With Infusional Dose-adjusted Etoposide/Vincristine/Doxorubicin/Bolus Cyclophosphamide/Dexamethasone and Rituximab (DA-EDOCH14-R) in Patients With Poor-prognosis Diffuse Large B-cell Lymphoma
- 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)
Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007, 136:276). Despite this improvement in outcome, the search for new treatment strategies should continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone (based upon data which demonstrated that the former was associated with enhanced Central Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would be feasible and might improve the outcome in this group of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone and dose-dense immunochemoterapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Poor prognosis DLBCL
- description
- Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3
- interventionNames
- Drug: Dexamethasone and dose-dense immunochemoterapy
Primary outcomes (1)
- measure
- efficacy of the EDOCH14-R scheme at an adjusted dose
- timeFrame
- Between December 2009 and January 2012
Secondary outcomes (1)
- measure
- hematological and extra-hematological toxicity of the EDOCH14-R scheme
- timeFrame
- Between december 2009 and January 2012
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signing the Informed Consent. * Histology: diffuse large B-cell lymphoma de novo (primary mediastinal B-cell lymphomas will be included provided that they have a mass greater than 7 cm in larger diameter) and follicular NHL grade 3b. * aaIPI: 2-3. * Age: Between 18 and 70 years. * General Condition (ECOG/WHO): Proper organic function, defined by: FEVI ≥ 40%, serum creatinine \< 150 µmol/L, serum bilirubin \< 30 µmol/L, control of other medical conditions such as: infection, leukocytes ≥ 3.5 x 109/l and platelets ≥ 100 x 109/l (except if they are caused by lymphomatous infiltration of bone marrow or of the spleen). Exclusion Criteria: * HIV-positive. * Pregnancy or breastfeeding. * Serious disease compromising the performance of the therapeutic regimen. * Recent history of another malignant disease (except skin cancer different from melanoma or carcinoma in-situ of the cervix), prior radiotherapy or chemotherapy, history of indolent lymphoma. * CNS infiltration at diagnosis.
References
Publications (1)
- DERIVEDGarcia-Suarez J, Flores E, Callejas M, Arribas I, Gil-Fernandez JJ, Olmedilla G, Curto N, Guillen H, Casco CR, Martin Y, Burgaleta C. Two-weekly dose-adjusted (DA)-EPOCH-like chemotherapy with high-dose dexamethasone plus rituximab (DA-EDOCH14-R) in poor-prognostic untreated diffuse large B-cell lymphoma. Br J Haematol. 2013 Feb;160(4):510-4. doi: 10.1111/bjh.12144. Epub 2012 Dec 11. PMID 23228045