drugset / Trial / NCT02267915

Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT

NCT02267915 ↗

Phase 2 Unknown 36 enrolled Spanish Lymphoma Cooperative Group
NaSingle-groupOpen-labelTreatment

Summary

1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy 2. Secondary endpoints: 1. Quality of response obtained after subcutaneous Rituximab maintenance. 2. Progression-Free Survival (PFS) 3. Overall Survival (OS) 4. Time to Next Therapy (TTNT) 5. Value of MRD in the disease outcome 6. Toxicity

Timeline

Start
2015-03
Primary completion
2019-12
Completion
2020-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1400 mg Subcutaneous

Indications