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Status unknownNCT01066429Updated Feb 12, 2010

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

A Phase 2 interventional study of Dexamethasone and dose-dense immunochemoterapy in Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Hospital Universitario Principe de Asturias. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-12.

Sponsored by Hospital Universitario Principe de Asturias · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

  • poor-prognosis diffuse large B-cell lymphoma
  • dose-adjusted
  • R-EDOCH-14
  • rituximab
  • age-adjusted IPI
  • toxicity
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Hospital Universitario Principe de Asturias is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Poor prognosis DLBCL

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

    Drug: Dexamethasone and dose-dense immunochemoterapy

Interventions

  • DrugDexamethasone and dose-dense immunochemoterapy

    Administration every 14 days of the EDOCH-R scheme.

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

06

What researchers measure

Primary outcomes

  1. efficacy of the EDOCH14-R scheme at an adjusted dose

    Time frame: Between December 2009 and January 2012

Secondary outcomes

  1. hematological and extra-hematological toxicity of the EDOCH14-R scheme

    Time frame: Between december 2009 and January 2012

07

Study locations

1 of 1 sites recruiting
  • Principe de Asturias University Hospital
    Alcala de Henares, Madrid 28805, Spain
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23228045 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01066429
Lead sponsor
Hospital Universitario Principe de Asturias
First posted
Feb 10, 2010
Start date
Dec 2009
Primary completion
Dec 2010 (estimated)
Completion
Dec 2012 (estimated)
Last update
Feb 12, 2010

Study contacts

Julio Garcia-Suarez, MD, PhD
Contact
jgarciasu.hupa@salud.madrid.org
34-91-8878100 ext. 2099
Julio Garcia-Suarez, MD, PhD
principal investigator · Service of Hematology, Principe de Asturias University Hospital,

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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