NCT02267915

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

An Open Multicenter Phase II Study of Efficacy and Toxicity of Maintenance Subcut. Rituximab After Induction With Rituximab in Patients With Relapsed or Refractory Mantle-cell Lymphoma Non-eligible for HSCT

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D. Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles. Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy. Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)

Conditions

• Mantle-cell Lymphoma

Interventions

Type	Name	Description
DRUG	subcutaneous Rituximab	MabThera 1400 mg solution for subcutaneous injection

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-12-01
• Completion: 2020-02-01
• First posted: 2014-10-20
• Last updated: 2020-01-27

Locations

15 sites across 1 country: Spain