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
Recruitment status was Recruiting
Sponsor:
Hospital Universitario Principe de Asturias
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
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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:
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:
- 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:
|
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 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
| 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 May 22, 2013