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

February 11, 2010 updated by: Hospital Universitario Principe de Asturias

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Recruiting
        • Principe de Asturias University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_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:
  • Rituximab
  • dexamethasone
  • Dose-dense therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
efficacy of the EDOCH14-R scheme at an adjusted dose
Time Frame: Between December 2009 and January 2012
Between December 2009 and January 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
hematological and extra-hematological toxicity of the EDOCH14-R scheme
Time Frame: Between december 2009 and January 2012
Between december 2009 and January 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Principe de Asturias

Investigators

  • Principal Investigator: Julio Garcia-Suarez, MD, PhD, Service of Hematology, Principe de Asturias University Hospital,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (ESTIMATE)

February 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA-EDOCH14-R/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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