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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
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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.
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
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marek Trneny, prof.,PhD. | Charles University General Hospital in Prague | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29083050 | Derived | Klener P, Fronkova E, Belada D, Forsterova K, Pytlik R, Kalinova M, Simkovic M, Salek D, Mocikova H, Prochazka V, Blahovcova P, Janikova A, Markova J, Obr A, Berkova A, Kubinyi J, Vaskova M, Mejstrikova E, Campr V, Jaksa R, Kodet R, Michalova K, Trka J, Trneny M. Alternating R-CHOP and R-cytarabine is a safe and effective regimen for transplant-ineligible patients with a newly diagnosed mantle cell lymphoma. Hematol Oncol. 2018 Feb;36(1):110-115. doi: 10.1002/hon.2483. Epub 2017 Oct 30. |
| Label | URL |
|---|---|
| Official Site of the Czech Lymphoma Study Group | View source |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Isolation of DNA from leukemized peripheral blood or infiltrated bone marrow will be used for set up of patient-specific primers for detection of minimal residual disease 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. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |