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

Completed

• Conditions: Mantle Cell Lymphoma

• Registration Number: NCT03054883
• Lead Sponsor: Czech Lymphoma Study Group

Brief 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

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2015-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Minimal residual disease (MRD) by PCR (polymerase chain reaction) after induction	After induction for all patients, who can be evaluated; through study completion, an average of 1 year.	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.
Progression-free survival and overall survival	max. 4 years	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