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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Hospital Universitario Principe de Asturias.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier:
NCT01066429
First received: February 8, 2010
Last updated: February 11, 2010
Last verified: December 2009

February 8, 2010
February 11, 2010
December 2009
December 2010   (final data collection date for primary outcome measure)
efficacy of the EDOCH14-R scheme at an adjusted dose [ Time Frame: Between December 2009 and January 2012 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01066429 on ClinicalTrials.gov Archive Site
hematological and extra-hematological toxicity of the EDOCH14-R scheme [ Time Frame: Between december 2009 and January 2012 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma
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

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.

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
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma (DLBCL)
Drug: Dexamethasone and dose-dense immunochemoterapy
Administration every 14 days of the EDOCH-R scheme.
Other Names:
  • Dose-dense therapy
  • Rituximab
  • dexamethasone
No Intervention: Poor prognosis DLBCL
Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3
Intervention: Drug: Dexamethasone and dose-dense immunochemoterapy
García-Suárez J, Flores E, Callejas M, Arribas I, Gil-Fernández JJ, Olmedilla G, Curto N, Guillén H, Casco CR, Martín 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2012
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Julio Garcia-Suarez, MD, PhD 34-91-8878100 ext 2099 jgarciasu.hupa@salud.madrid.org
Spain
 
NCT01066429
DA-EDOCH14-R/07
No
Hematology Service, Hospital Principe de Asturias
Hospital Universitario Principe de Asturias
Not Provided
Principal Investigator: Julio Garcia-Suarez, MD, PhD Service of Hematology, Principe de Asturias University Hospital,
Hospital Universitario Principe de Asturias
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP