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

Mantle Cell Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054883
• Other study ID #: CLSG-MCL-01
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: February 13, 2017
• Start date: April 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Czech Lymphoma Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Czech Lymphoma Study Group	Ministry of Health, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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
Secondary	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.	After induction for all patients, who can be evaluated; through study completion, an average of 1 year.

External Links

•   Official Site of the Czech Lymphoma Study Group