Mantle-cell Lymphoma Clinical Trial
Official title:
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
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
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)
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