NCT03054883

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Czech Lymphoma Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Mantle Cell Lymphoma

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-12-31
• Completion: 2016-12-31
• First posted: 2017-02-16
• Last updated: 2017-02-16