DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diffuse Large B-Cell Lymphoma (DLBCL)

Intervention / Treatment
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* Drug: Dexamethasone and dose-dense immunochemoterapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Poor prognosis DLBCL<br>Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3 | Drug: Dexamethasone and dose-dense immunochemoterapy<br>* Administration every 14 days of the EDOCH-R scheme.<br>* Other names: dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of the EDOCH14-R scheme at an adjusted dose |  | Between December 2009 and January 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematological and extra-hematological toxicity of the EDOCH14-R scheme |  | Between december 2009 and January 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor-prognosis diffuse large B-cell lymphoma, dose-adjusted, R-EDOCH-14, rituximab, age-adjusted IPI, toxicity