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

NCT01066429 | Unknown Phase 2

• 1 other identifier: DA-EDOCH14-R/07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

poor-prognosis diffuse large B-cell lymphoma; dose-adjusted; R-EDOCH-14; rituximab; age-adjusted IPI; toxicity

Outcome Measures

Primary Outcomes (1)

• efficacy of the EDOCH14-R scheme at an adjusted dose

  Between December 2009 and January 2012

Secondary Outcomes (1)

• hematological and extra-hematological toxicity of the EDOCH14-R scheme

  Between december 2009 and January 2012

Study Arms (1)

Poor prognosis DLBCL

NO INTERVENTION

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

Drug: Dexamethasone and dose-dense immunochemoterapy

Interventions

Dexamethasone and dose-dense immunochemoterapy DRUG

Administration every 14 days of the EDOCH-R scheme.

Also known as: Dose-dense therapy, Rituximab, dexamethasone

Poor prognosis DLBCL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Principe de Asturias: lead

Study Sites (1)

Principe de Asturias University Hospital

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 23228045 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Dexamethasone; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Julio Garcia-Suarez, MD, PhD

  Service of Hematology, Principe de Asturias University Hospital,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Garcia-Suarez, MD, PhD

CONTACT

34-91-8878100; jgarciasu.hupa@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: February 12, 2010

Record last verified: 2009-12

Locations

ES (1)