DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01066429|
Recruitment Status : Unknown
Verified December 2009 by Hospital Universitario Principe de Asturias.
Recruitment status was: Recruiting
First Posted : February 10, 2010
Last Update Posted : February 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma (DLBCL)||Drug: Dexamethasone and dose-dense immunochemoterapy||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2012|
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.
- efficacy of the EDOCH14-R scheme at an adjusted dose [ Time Frame: Between December 2009 and January 2012 ]
- hematological and extra-hematological toxicity of the EDOCH14-R scheme [ Time Frame: Between december 2009 and January 2012 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066429
|Contact: Julio Garcia-Suarez, MD, PhD||34-91-8878100 ext email@example.com|
|Principe de Asturias University Hospital||Recruiting|
|Alcala de Henares, Madrid, Spain, 28805|
|Contact: Julio Garcia-Suarez, MD, PhD 34-91-8878100 ext 2099 firstname.lastname@example.org|
|Principal Investigator:||Julio Garcia-Suarez, MD, PhD||Service of Hematology, Principe de Asturias University Hospital,|