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

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

Detailed Description
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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)

Official Title
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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

Conditions
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Mantle-cell Lymphoma

Intervention / Treatment
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* Drug: subcutaneous Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Basal diagnosis of mantle-cell lymphoma in relapse or refractory. Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-5. Age > 18 years. One or maximum two prior chemotherapy or immunochemotherapy lines. Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation. No clinical evidence of CNS involvement Signed informed consent Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL. Pregnant or lactating woman. FCBP must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study Exclusion Criteria: Prior organ transplantation. HIV positive. HBV related disease Any serious active disease or co-morbid medical condition (according to the investigator's decision) Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma. Less than 50% of tumor response. Platelet counts less than 50 x 109/L. Neutrophil counts less than 1.0 x 109/L.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subcutaneous rituximab<br>MabThera 1400 mg solution for subcutaneous injection | Drug: subcutaneous Rituximab<br>* MabThera 1400 mg solution for subcutaneous injection<br>* Other names: MABTHERA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression, (Measured from achievement of response -partial or complete- to to disease progression) | 2 years after last patient randomized in maintenance | 2 YEARS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT