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

Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01066429
• Other study ID #: DA-EDOCH14-R/07
• Status: Recruiting
• Phase: Phase 2
• First received: February 8, 2010
• Last updated: February 11, 2010
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2009
• Source: Hospital Universitario Principe de Asturias
• Contact: Julio Garcia-Suarez, MD, PhD
• Phone: 34-91-8878100
• Email: jgarciasu.hupa[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Dexamethasone and dose-dense immunochemoterapy
Administration every 14 days of the EDOCH-R scheme.

Locations

Country	Name	City	State
Spain	Principe de Asturias University Hospital	Alcala de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of the EDOCH14-R scheme at an adjusted dose		Between December 2009 and January 2012	Yes
Secondary	hematological and extra-hematological toxicity of the EDOCH14-R scheme		Between december 2009 and January 2012	Yes