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

NCT ID: NCT01066429

Last Updated: 2010-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-12-31

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.

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

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Poor prognosis DLBCL

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

Group Type: NO_INTERVENTION

Dexamethasone and dose-dense immunochemoterapy

Intervention Type: DRUG

Administration every 14 days of the EDOCH-R scheme.

Interventions

Dexamethasone and dose-dense immunochemoterapy

Administration every 14 days of the EDOCH-R scheme.

Intervention Type: DRUG

Other Intervention Names

Dose-dense therapy; Rituximab; dexamethasone

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Principe de Asturias

OTHER

Sponsor Role: lead

Responsible Party

Hospital Principe de Asturias

Principal Investigators

Julio Garcia-Suarez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service of Hematology, Principe de Asturias University Hospital,

Locations

Principe de Asturias University Hospital

Alcalá de Henares, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Julio Garcia-Suarez, MD, PhD

Role: CONTACT

jgarciasu.hupa@salud.madrid.org

34-91-8878100 ext. 2099

Facility Contacts

Julio Garcia-Suarez, MD, PhD

Role: primary

jgarciasu.hupa@salud.madrid.org

34-91-8878100 ext. 2099

References

Garcia-Suarez J, Flores E, Callejas M, Arribas I, Gil-Fernandez JJ, Olmedilla G, Curto N, Guillen H, Casco CR, Martin Y, Burgaleta C. Two-weekly dose-adjusted (DA)-EPOCH-like chemotherapy with high-dose dexamethasone plus rituximab (DA-EDOCH14-R) in poor-prognostic untreated diffuse large B-cell lymphoma. Br J Haematol. 2013 Feb;160(4):510-4. doi: 10.1111/bjh.12144. Epub 2012 Dec 11.

Reference Type: DERIVED

PMID: 23228045 (View on PubMed)

Other Identifiers

DA-EDOCH14-R/07

Identifier Type: -

Identifier Source: org_study_id