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Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.
Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome. There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%. The combination of RCHOP with new drugs is an attractive approach to treat these patients. The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with an aIPI \> 1 or an aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal.)
Details
| Lead sponsor | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 121 |
| Start date | 2013-10-03 |
| Completion | 2018-08 |
Conditions
- Diffuse, Large B-Cell, Lymphoma
Interventions
- Bortezomib
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Prednisone
- Vincristine
Primary outcomes
- Proportion of patients with Event-Free Survival at 2 years. — During treatment period, there will be assessments every 2 cycles. After end of treatment every 3 month the first year, every 6 months the second year and annually from 3rd to 5th year
To evaluate the proportion of patients with event-free survival at 2 years in patients diagnosed of DLBCL with aIPI \> 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL). UNL= Upper Normal Limit.
Countries
Spain