Know Cancer

or
forgot password

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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma (DLBCL)

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of the EDOCH14-R scheme at an adjusted dose

Outcome Time Frame:

Between December 2009 and January 2012

Safety Issue:

Yes

Principal Investigator

Julio Garcia-Suarez, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Service of Hematology, Principe de Asturias University Hospital,

Authority:

Spain: Ethics Committee

Study ID:

DA-EDOCH14-R/07

NCT ID:

NCT01066429

Start Date:

December 2009

Completion Date:

December 2012

Related Keywords:

  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • poor-prognosis diffuse large B-cell lymphoma
  • dose-adjusted
  • R-EDOCH-14
  • rituximab
  • age-adjusted IPI
  • toxicity
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location