Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose Therapy

Study Overview
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Brief Summary
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This is an observational study aimed to analyze the effectiveness of treatment of patients with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab, cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin): R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction.

Detailed Description
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This is an observational study considered for patients with mantle cell lymphoma meeting the basic inclusion criteria. The study will enrol patients who will be treated according to standard protocol used in the hematologic department. Scheme of treatment: alternating cycles of R-CHOP and R-AraC: R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. Baseline procedures: CT or PET-CT (positron emission tomography with computed tomography)before starting treatment, after 3 cycles and at the end of treatment (after 6 cycles) bone marrow examination before therapy, after 3 cycles and after completion of induction maintenance rituximab based of standards of each centre The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction. Primary objectives include response after induction by PET-CT and PFS (progression-free survival). Secondary objectives include OS (overall survival), and prognostic significance of minimal residual disease detection after completion of induction

Official Title
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Observational Study for Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) Not Eligible for High-dose Therapy According to the Protocol Alternating R-CHOP and R-cytarabine Chemotherapy Regimen (3+3 Cycles)

Conditions
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Mantle Cell Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of MCL (hematopathologic examination in the reference centre, with evidence of cyclin D1 or translocation t(11;14) ) not eligible for high-dose therapy with autologous stem cell transplantation eligible for R-CHOP or R-COEP-based therapy signed informed consent form with the study and data processing Exclusion Criteria: non compliance of a patient CNS (central nervous system) involvement with lymphoma ECOG (Eastern Cooperative Oncology Group) >3 or active uncontrolled comorbidities

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response | PET-CT after induction, and bone marrow examination after induction | After induction for all patients, who can be evaluated; through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival and overall survival | PFS will be calculated from initiation of therapy until lymphoma relapse / progression or death from any cause; OS will be calculated from initiation of therapy until death from any cause | max. 4 years | 
| Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction | After completion of induction MRD will be evaluated by PCR in the peripheral blood and bone marrow in those patients with available disease markers, i.e. primers detecting the translocation t(11;14) or unique IgVH rearrangement. | After induction for all patients, who can be evaluated; through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mantle Cell Lymphoma, minimal residual disease, cytosine arabinoside