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

Sponsor

Hospital Universitario Principe de Asturias (Other)

Overall Status

Unknown status

CT.gov ID

NCT01066429

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma (DLBCL)	Drug: Dexamethasone and dose-dense immunochemoterapy	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Poor prognosis DLBCL Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3	Drug: Dexamethasone and dose-dense immunochemoterapy Administration every 14 days of the EDOCH-R scheme. Other Names: Dose-dense therapy Rituximab dexamethasone

Arm

Intervention/Treatment

No Intervention: Poor prognosis DLBCL

Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3

Drug: Dexamethasone and dose-dense immunochemoterapy

Administration every 14 days of the EDOCH-R scheme.

Other Names:

Dose-dense therapy

Rituximab

dexamethasone

Outcome Measures

Primary Outcome Measures

efficacy of the EDOCH14-R scheme at an adjusted dose [Between December 2009 and January 2012]

Secondary Outcome Measures

hematological and extra-hematological toxicity of the EDOCH14-R scheme [Between december 2009 and January 2012]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.