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

Primary Purpose

Diffuse Large B-Cell Lymphoma (DLBCL)

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Dexamethasone and dose-dense immunochemoterapy
Sponsored by
Hospital Universitario Principe de Asturias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma (DLBCL) focused on measuring poor-prognosis diffuse large B-cell lymphoma, dose-adjusted, R-EDOCH-14, rituximab, age-adjusted IPI, toxicity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Principe de Asturias University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Poor prognosis DLBCL

Arm Description

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

Outcomes

Primary Outcome Measures

efficacy of the EDOCH14-R scheme at an adjusted dose

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2010
Last Updated
February 11, 2010
Sponsor
Hospital Universitario Principe de Asturias
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1. Study Identification

Unique Protocol Identification Number
NCT01066429
Brief Title
DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Principe de Asturias

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma (DLBCL)
Keywords
poor-prognosis diffuse large B-cell lymphoma, dose-adjusted, R-EDOCH-14, rituximab, age-adjusted IPI, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Poor prognosis DLBCL
Arm Type
No Intervention
Arm Description
Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and dose-dense immunochemoterapy
Other Intervention Name(s)
Dose-dense therapy, Rituximab, dexamethasone
Intervention Description
Administration every 14 days of the EDOCH-R scheme.
Primary Outcome Measure Information:
Title
efficacy of the EDOCH14-R scheme at an adjusted dose
Time Frame
Between December 2009 and January 2012
Secondary Outcome Measure Information:
Title
hematological and extra-hematological toxicity of the EDOCH14-R scheme
Time Frame
Between december 2009 and January 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Garcia-Suarez, MD, PhD
Phone
34-91-8878100
Ext
2099
Email
jgarciasu.hupa@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Garcia-Suarez, MD, PhD
Organizational Affiliation
Service of Hematology, Principe de Asturias University Hospital,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Principe de Asturias University Hospital
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Garcia-Suarez, MD, PhD
Phone
34-91-8878100
Ext
2099
Email
jgarciasu.hupa@salud.madrid.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
23228045
Citation
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.
Results Reference
derived

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

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