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
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy 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:


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

Primary Outcome Measures:
  • 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:
  • 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 Interventions
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:
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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    jgarciasu.hupa@salud.madrid.org   
Sponsors and Collaborators
Hospital Universitario Principe de Asturias
Investigators
Principal Investigator: Julio Garcia-Suarez, MD, PhD Service of Hematology, Principe de Asturias University Hospital,
  More Information

No publications provided by Hospital Universitario Principe de Asturias

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hematology Service, Hospital Principe de Asturias
ClinicalTrials.gov Identifier: NCT01066429     History of Changes
Other Study ID Numbers: DA-EDOCH14-R/07
Study First Received: February 8, 2010
Last Updated: February 11, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario Principe de Asturias:
poor-prognosis diffuse large B-cell lymphoma
dose-adjusted
R-EDOCH-14
rituximab
age-adjusted IPI
toxicity

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Rituximab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014