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

Madrid Health Service

Status and phase

Unknown

Phase 2

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Treatments

Drug: Dexamethasone and dose-dense immunochemoterapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01066429

DA-EDOCH14-R/07

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.