Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Keywords
poor-prognosis diffuse large B-cell lymphoma, dose-adjusted, R-EDOCH-14, rituximab, age-adjusted IPI, toxicity
Brief summary
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.
Detailed description
Medication, Dose and Method for Administration: * Rituximab: 375 mg/m2, endovenous, according to the protocol of the service, day 1 (except in the first cycle, in which it will be on day 5). * Etoposide: 50 mg/m2/day, in continuous 24-hour infusion, days 1 to 4. * Adriamycin: 10 mg/m2/day, in continuous 24-hour infusion of, days 1 to 4. * Vincristine: 0.4 mg/m2/day, in continuous 24-hour infusion, days 1 to 4 * Dexamethasone: 40 mg, endovenous, days 1 to 5. Followed by prednisone 30 mg (day +6), 20 mg (day +7), and 10 mg (day +8). * Cyclophosphamide: 750 mg/m2, endovenous, in 30 minutes, day 5, after ending the continuous infusion of adriamycin, etoposide and vincristine. * MESNA (If the dose of Cyclophosphamide is \> 1 g/m2
Interventions
DRUGDexamethasone and dose-dense immunochemoterapy
Administration every 14 days of the EDOCH-R scheme.
Sponsors
Hospital Universitario Principe de Asturias
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of the EDOCH14-R scheme at an adjusted dose | Between December 2009 and January 2012 |
Secondary
| Measure | Time frame |
|---|---|
| hematological and extra-hematological toxicity of the EDOCH14-R scheme | Between december 2009 and January 2012 |
Countries
Spain
Contacts
Primary ContactJulio Garcia-Suarez, MD, PhD
Outcome results
None listed