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

This study is currently recruiting participants.
Verified December 2009 by Hospital Universitario Principe de Asturias

First Received on February 8, 2010.  
Last Updated on February 11, 2010  
History of Changes
This Clinical Trial Sponsored By: Hospital Universitario Principe de Asturias
Information provided by: Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier: NCT01066429
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Diffuse Large B-Cell Lymphoma (DLBCL) Drug: Dexamethasone and dose-dense immunochemoterapy Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone Sodium Phosphate
Rituximab

U.S. FDA Resources

Further study details as provided by Hospital Universitario Principe de Asturias:

Primary Outcome Measures For Clinical Trial:

  • efficacy of the EDOCH14-R scheme at an adjusted dose [ Time Frame: Between December 2009 and January 2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • hematological and extra-hematological toxicity of the EDOCH14-R scheme [ Time Frame: Between december 2009 and January 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

No Study 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

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066429

Contacts
Contact: Julio Garcia-Suarez, MD, PhD 34-91-8878100 ext 2099 jgarciasu.hupa@salud.madrid.org

Locations
Spain
Principe de Asturias University Hospital Recruiting
Alcala de Henares, Madrid, Spain, 28805
Contact: Julio Garcia-Suarez, MD, PhD     34-91-8878100 ext 2099    

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