An observational study in Mantle Cell Lymphoma, sponsored by Czech Lymphoma Study Group. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Czech Lymphoma Study Group · Observational
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.
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:
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
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 73 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Czech Lymphoma Study Group is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Elderly and/or comorbid patients with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem cell transplantation, eligible for R-CHOP or R-COEP (rituximab, cyclophosphamide, oncovin, etoposide, prednison) based therapy.
Exclusion Criteria:
Overall response
PET-CT after induction, and bone marrow examination after induction
Time frame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
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
Time frame: 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.
Time frame: After induction for all patients, who can be evaluated; through study completion, an average of 1 year.
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Czech Lymphoma Study Group