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Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed
Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
Details
| Lead sponsor | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 61 |
| Start date | 2009-07 |
| Completion | 2016-07 |
Conditions
- Non-Hodgkin's Lymphoma
Interventions
- Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Primary outcomes
- Response Rate — 7 years
The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL Complete Remission (CR): Nodes returned to normal (if GTD \>15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA \>10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD Progressive Disease (PD): SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion
Countries
Spain