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

Czech Lymphoma Study Group

Status: Completed

Conditions: Mantle Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT03054883

CLSG-MCL-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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